Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Pleural Effusion, Malignant

Pleural Neoplasms

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Doxycycline

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Indwelling Catheter

Quality-of-Life Assessment

Questionnaire Administration

Survey Administration

David Ost

This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.

PRIMARY OBJECTIVES:

I. To obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE).

OUTLINE: Patients choose 1 of 2 groups.

GROUP I: Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

GROUP II: Patients undergo IPC placement.

After completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.

Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions

A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal.

Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement.

Will use paired t-test to compare baseline and 1 month Borg scores and utilities. A generalized linear model will be used to evaluate whether other variables have any impact on the pairwise differences between baseline and 1 month.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Urinary Retention

Lower Urinary Tract Symptoms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urological Manifestations

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Post-operative placement of temporary prostatic stent (EXIME)

Post-operative placement of indwelling catheter

Placement of temporary prostatic stent (Exime®) following the procedure described in the product information

Temporary prostatic stent (Exime®)

Indwelling catheter

Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM

Juan I Martínez-Salamanca, MD

The goal of this single-centre prospective randomized clinical trial is to compare the post-operative use of temporary prostatic stent (Group 1) vs indwelling catheter (Group 2) in patients undergoing cryotherapy for targeted therapy of localized prostate cancer, transurethral water vapor energy ablation (REZUM) or transperineal laser ablation of the prostate with EchoLaser™ system for the treatment of benign prostatic hyperplasia (BPH)

The main questions are:

* Difference in quality of life, Lower Urinary Tract Symptoms (scored with IPSS, International Prostate Symptom Score), urinary continence symptoms (scored with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ICIQ-UI-SF) and patient satisfaction between indwelling catheter and temporary prostatic stent (Exime®) score with a non-validated questionnaire (Stent/catheter-related urinary symptoms questionnaire)
* Difference in side effects and complications between indwelling catheter and temporary prostatic stent (Exime®)

A total 120 of patients will be enrolled (Group 1: 60; Group 2: 60) with a 1:1 randomization ratio. The follow-up duration will be 6 months.

Prospective randomized clinical trial divided in 3 cohorts: HERMES_CRYO (cryotherapy for targeted therapy of localized prostate cancer), HERMES_REZUM \[water vapor energy ablation for the treatment of benign prostatic hyperplasia (BPH)\], and HERMES_LASER \[ELESTA ECHOLASER® for the treatment of benign prostatic hyperplasia (BPH)\].

In each cohort, two arms will be compared: temporary prostatic stent vs indwelling catheter with a 1:1 randomization ratio.

To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in Patients Undergoing Minimally Invasive Procedures for the Treatment of Localized Prostate Cancer or Benign Prostatic Hyperplasia (HERMES)

HERMES Study: A Randomized Clinical Trial To Evaluate Lower Urinary Tract Symptoms Differences Between Indwelling Catheter And Temporary Prostatic Stent In Patients Undergoing Minimally Invasive Procedures For The Treatment Of Localized Prostate Cancer Or Benign Prostatic Hyperplasia

Evaluation of impact on patient quality of life associated with the urinary device will be based on the sixth question (Q6) of a non validated questionnaire (Stent/catheter-related urinary symptoms questionnaire), defined as:

Q6: "How much has the bladder catheter/Exime affected your quality of life?" Quantitative answer, ranging from 0 to 10. Being zero, not affected; and being ten, very affected

Evaluation will be based on the first five questions (Q1 - Q5) of a non validated questionnaire with quantitative answers ranging from 0 to 10, defined as:

Q1:How much urine leakage have you had while carrying the bladder catheter or the Exime® device? (0: none -\> 10 a lot of leakage = need to use several diapers) Q2. How much pain, discomfort or spasms have you had in relation to the catheter/Exime®? (0: none -\> 10: a lot of pain = need for prescribed analgesia) Q3. How much bleeding have you had with urine while wearing the catheter/Exime®? (0: none -\> 10: a lot of bleeding = need for change of clothing) Q4. How much has the urine been different? (darker than usual, worse odor, or sediment)? (0: nothing -\> 10: very strong odor, very dark urine, presence of lumps) Q5. Have you had any problems in handling the catheter? (0: no problems at all -\> 10: many problems)

Evaluation of satisfaction of patients associated with the device will be based on the seventh question (Q7) of a non validated questionnaire (Stent/catheter-related urinary symptoms questionnaire), defined as:

Q7. What is your degree of satisfaction while wearing the catheter/Exime®? Quantitative answer, ranging from 0 to 10. Being zero, not satisfied at all; and being ten, completely satisfied

Evaluation of impact of the device on LUTS will be based on a validated questionnaire administered before the device-placement, at device-removal, at 4 weeks and finally at 6 months after treatment:

- International Prostate Symptom Score (IPSS), min 0 - max 35 points, in which higher values are associated with worsening urinary symptoms

Evaluation of perioperative events (\< or = 24h after treatment) defined as complications (classified according to the Clavien - Dindo scale), presence of haematuria, pain (based on visual analogue pain score), occurence of acute urinary retention or need to perform urinary catheter bladder washout.

Evaluation of postoperative events (\>24h-1week) defined as acute urinary retention or need to perform urinary catheter bladder washout, need to change urinary catheter or presence of urinary tract infection (presence of fever or need to change antibiotic therapy) and others complications (classified according to the Clavien - Dindo scale)

Evaluation of overall satisfaction will be based on the question "How satisfied are you overall with the treatment you have received? (Quantitative answer, ranging from 0 to 10. Being zero, not satisfied at all; and being ten, completely satisfied) administered at 4 week post-treatment.

Maximal flow rate \[Q max (ml/s)\] will be evaluated performing a uroflowmetry at baseline, at week 4, and finally at 6 months after treatment.

Evaluation of impact of the device on continence symptoms will be based on a validated questionnaire administered before the device-placement, at device-removal, at 4 weeks and finally at 6 months after treatment:

- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF): min 0 - max 21 points, the higher the score, the more severe is the urinary incontinence, but there is no normal score.

Lyx Institute

Ascites

The tunneled catheter is an implant product that enables the drainage of effusion accumulations from serous body cavities so that the symptoms caused by an effusion are relieved by draining off the accumulated fluids.

Natasa Mitrovic, MSc

Heidrun Steinle, Dr

The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.

The main questions of this study are:

* Does the device function as intended?
* Are there any other safety risks that have not been identified?
* Does it lower the symptoms of the patients as intended?

Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.

The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU).

This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.

PMCF Study of the CE-marked Drainova® ArgentiC Catheter

Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter

Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).

Occurrence of catheter blockage, occlusion or displacement

Must meet the following items:

1. Successful placement at the defined location
2. Feasibility of initial drainage of fluid (volume in ml)

Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies

Quality-of-life will be assessed by QoL questionnaire

LS medcap GmbH

ewimed GmbH

Pain

Central Nervous System Depressants

Analgesics

Anesthetics

Propofol

Alfentanil

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

Patients in this arm will undergo SVP insertion in local anesthesia (LA)

Patients in this arm will undergo SVP insertion in local anesthesia and PCS (LA+PCS)

In addition to LA, patients in the study group are able to self-administer a combination of propofol and alfentanil using a patient-controlled sedation pump. The pump enables the patient via a hand-held button to trigger the release of a single bolus of 0.5ml containing 4.5mg propofol and 25µg alfentanil under an 10second period. This results in a maximal possible amount of 6 bolus doses per minute.

Propofol + Alfentanil

Stefanie Seifert

Knut Taxbro

The goal of the study is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces patient-reported pain perception during implantation of subcutaneous venous port (SVP).

The main question it aims to answer: How much pain did you (patient) experience during SVP-implantation Several other questions will be answered regarding: patient´s perception of the procedure, complication rate, procedure data.

The study contains two groups which will be compared. Control group: will do SVP implantation under local anaesthesia Study group: will do SVP implantation under local anaesthesia and patient-controlled sedation.

The patients are asked to complete a questionnaire postoperatively which contains questions on pain perception and satisfaction.

The study is an open multicentre randomized controlled trial with a study and a control arm in a 1:1 ratio. Patients will be randomized to either a control arm of LA for SVP-implantation or a study arm of PCS with propofol and alfentanil as adjunct to LA for SVP-implantation. The aim is to randomize 340 patients with an estimated patient recruitment over 18 months with a following 6 months of data cleaning and analysis. The trial will be performed at two centres; County Hospital Ryhov, Jönköping, Sweden and University Hospital Linköping, Sweden. SVP implantation procedure and perioperative time period is estimated to 2-4 hours. The primary endpoint is assessment of patients´ self-reported pain perception. Secondary outcomes include patient satisfaction, implantation conditions, sedation level, sedative and analgesic medication consumption, procedural time consumption as well as safety aspects, adverse events and estimation of perioperative experience. Participation in the trial ends after telephone inquiry one day postoperatively.

Control arm:

SVP-implantation in LA:

Subcutanous venous ports were introduced in 1981. A SVP is a small device around 3cm in diameter with an injectable membrane buried just under the skin. It is connected to a thin tube with its tip in a large bore vein. Access to the SVP is achieved by puncturing the skin with a needle.

Local anaesthetic causes the absence of pain sensation in the location where applied by decreasing the rate of depolarization and repolarization of excitable membranes such as nociceptors and nerves. The most commonly used solutions are from the amide group differing in pharmacokinetics. In order to reduce a burning sensation on infiltration substances can be combined with sodium bicarbonate. There will be no restrictions in the choice of LA-solution being left up to local practice at participating sites. With the beginning of the procedure LA is subcutaneously applied to patients in both groups. LA used at participating centres are Mepivacaine 10mg/ml, 20-40ml subcutaneously or Lidnocaine 10mg/ml, 20-40 ml subcutaneously.

Study arm:

SVP-implantation in LA and PCS:

In addition to LA, patients in the study group are able to self-administer a combination of propofol and alfentanil using a patient-controlled sedation pump. The pump enables the patient via a hand-held button to trigger the release of a single bolus of 0.5ml containing 4.5mg propofol and 25µg alfentanil under an 10 second period. This results in a maximal possible amount of 6 bolus doses per minute.

Propofol is a short-acting anaesthetic agent commonly used for general anaesthesia and procedural sedation. Several mechanisms of action have been proposed both through potentiation of GABAA receptor activity and in higher doses behaving as GABAA receptor agonist. When used for intravenous sedation a single dose wears off within minutes demanding for continuous or intermittent application.

Alfentanil is a short-acting synthetic opioid analgesic agent with rapid onset of effects at µ-opioid receptors. These properties make it suitable to provide analgesia for brief procedures and to infuse for longer procedures and yet provide relatively rapid recovery.

Rescue sedation will be available to patients in both groups on the patient´s or operator´s demand. Rescue sedation consists of propofol and alfentanil administered by the clinician and is documented in the e-CRF.

Setting:

This trial will be carried out in the following anaesthesia departments:

OP/IVA clinic, County Hospital Ryhov, Sweden AnOpIVA clinic, University Hospital Linköping, Sweden

Participants will be instructed on use of the PCS pump (Syramed µSP6000, Arcomed AG, Switzerland) by a nurse anesthetist. The syringe is loaded with 36 ml propofol (10 mg/ml) and 4 ml alfentanil (0.5 mg/ml). Each time the patient presses the handheld button, an aliquot of 0.5 ml is injected (4.5 mg propofol/0.025 mg alfentanil). The injection time is set to 10 s, restricting self-administration to a maximum of 6 bolus doses per minute corresponding to 27 mg propofol and 0.15 mg alfentanil per minute. No lockout period is applied. Local anaesthesia is injected in the operating site. Vital parameters prior to the procedure are recorded. Patients are monitored using electrocardiography for heartrate (HR), non-invasive blood pressure (BP), oxygen saturation (SpO2), and respiratory rate (RR) at 5-min intervals during the procedure. Bradycardia is defined as HR \<40 beats/min, tachycardia as HR \>100 beats/min, hypotension as systolic BP \< 90 mmHg or a decrease of \>30% from baseline, hypoxia as SpO2 \<90% or a decrease of \>5% from baseline, and bradypnea as RR of \<8 breaths per minute. Supplemental oxygen via a capnograph-fitted nasal cannula is administered to all patients at 2 L/min during the procedure. The Observer's Assessment of Alertness/Sedation score (OAA/S) \[9\] is used to determine the sedation level during the four procedural steps: 1) sterile swabbing, 2) injection of LA, 3) catheter tunneling, and 4) sterile drape removal. The operating anesthesiologist assesses the operating conditions on a 4 point scale with 1 enabling the operator to perform the procedure without time delay and 4 having to abort the procedure. Puncture attempt is defined as continuous needle advancement to establish vein puncture. An unvalidated patient perception assessment tool with seven dimensions applying the NRS is used to evaluate patient perception. QoR-15 will be measured att 3 timepoints. Preoperatively, postoperatively before patient discharge and one day postoperatively.

Patient-Controlled Sedation in Port Implantation (PACSPI-2)

Patient-Controlled Sedation in Port Implantation (PACSPI-2) -a Randomized Controlled Trial

All IPD that underlie results in a publication will be available for sharing on request

NRS Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire.

NRS Participants assessment of overall satisfaction experienced during the procedure using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire

Respiratory and circulatory complications as well as mechanical complications during the procedure bradycardia: defined as heart \< 40/minutes during the procedure Hypoxia: defined as Oxygen saturation \<90% or significant drop from baseline (\>5% SaO2 drop) during the procedure Airway intervention: defined as intervention by staff with chin lift during the procedure bradypnea: defined as respiratory rate \<8/minute during the procedure

Sedation levels according to Observers Assessment of Alertness/Sedation scale 5: responds readily to naame spoken in normal tone 4: responds lethargically to name spoken in normal tone 3: responds only after name is called loudly, repeatedly, or both 2: responds only after mild prodding or shaking

1: responds only after painful trapezius squeeze 0: does not respond to painful trapezius squeeze

Quality of Recovery according to QoR-15 Have you had any of the following in the last 24 hours? 10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\])

1. Able to breathe easily
2. Been able to enjoy food
3. Feeling rested
4. Have had a good sleep
5. Able to look after personal
6. Able to communicate with family or friends
7. Getting support from hospital doctors and nurses
8. Able to return to work or usual home activities
9. Feeling comfortable and in control
10. Having a feeling of general well-being
11. Moderate pain
12. Severe pain
13. Nausea or vomiting
14. Feeling worried or anxious
15. Feeling sad or depressed

Participants assessment of the importance of receiving sedatives and being in control of sedation on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions	NCT03465774	Pleural Neoplas...	Doxycycline Indwelling Cath... Quality-of-Life... Questionnaire A... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in Patients Undergoing Minimally Invasive Procedures for the Treatment of Localized Prostate Cancer or Benign Prostatic Hyperplasia (HERMES)	NCT05851521	Lower Urinary T... Prostatic Hyper... Prostatic Cance... Urinary Retenti...	Temporary prost... Indwelling cath...	18 Years - 85 Years	Lyx Institute
PMCF Study of the CE-marked Drainova® ArgentiC Catheter	NCT06436807	Pleural Effusio... Pleural Effusio... Ascites Ascites, Malign...	Indwelling cath...	18 Years -	ewimed GmbH
Patient-Controlled Sedation in Port Implantation (PACSPI-2)	NCT05688384	Pain Patient Satisfa... Cancer Venous Puncture	Propofol + Alfe...	18 Years - 110 Years	Region Jönköping County

Spots Global Cancer Trial Database for indwelling catheter