Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Infections

Rare Diseases

Prostatic Neoplasms

Carcinoma, Renal Cell

Congenital Abnormalities

Nephritis

Kidney Calculi

Nephrolithiasis

Tuberculosis

Hydronephrosis

Kidney Neoplasms

Tuberculosis, Renal

Calculi

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Urolithiasis

Urinary Calculi

Pathological Conditions, Anatomical

Tuberculosis, Extrapulmonary

Renal Cell Carcinoma

Jörg Simon, PD Dr. med.

Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

The objective of this observational study is to collect systematically and proactively data regarding the Aesculap® DS Titanium Ligation Clip under daily clinical practice when used in urology in different indications.

The hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the Instructions for Use (IfU). The observed rate through the total number of clips might be a valuable parameter and could influence future research.

Furthermore, this study is one of the PMCF measures which enable the manufacturer to monitor the safety and performance of the Aesculap® DS Titanium Ligation Clips. The products bear the CE-marking and are routinely used within this institution for the above-mentioned procedures.

DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Estimated operative time from first cut to last stitch

Length of patient's stay in hospital after surgery

The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects

Slippage / movement of the Aesculap® DS Titanium Ligation Clip is an observable slippage, movement, or rotation after the clip was successfully applied and the application forceps was removed. The number of observed slippage / movement of the clip will be documented on the CRF, the clip size, step of the procedure and further measures were necessary, i.e. removal of the clip or application of another clip, will be documented.

In the end the rate will be brought in relationship to the overall number of applied clips. Thus, the number of applied clips is documented, for each clip size.

* Postoperative bleedings
* Infections
* Urine extravasation in partial nephrectomy
* Prolonged urinary catheter drainage in radical prostatectomies
* Ileus
* Venous thrombo-embolic events
* Sepsis
* Other

Aesculap AG

non-stented volunteers to receive ultrasound for peristalsis changes detection

patients who receive stent, and to receive ultrasound for peristalsis changes detection in their stented and non-stented ureter

patients who need to receive stent as per standard of care

Ureteral Stent

Ben Chew, MD

The purpose of the study is to investigate the impact of ureteral stents on the functioning of ureteral peristalsis (normal contractions in the ureteral organ muscle).

Ureteral stents are commonly used in the field of urology to maintain urinary drainage and are inserted into ureters of patients who suffer from kidney stones, urinary tract infections or cancer. Usually the muscle cells of the ureter contract in a coordinated fashion (peristalsis) in order to provide urinary flow from the kidney into the bladder. By inserting a stent these contractions are disrupted, eventually resulting in a loss of peristalsis. This phenomena is accompanied by swelling of the kidney and pain, which are well-known negative side effects of stents. To avoid stent-related morbidity and improve patients care this issue needs to be investigated further. A first step is to analyse the impact of stents on peristalsis and to possibly bring these results into context with hypothesised molecular mechanisms involved in peristalsis.

The Impact of Ureteral Stents on Peristalsis

before and after stent insertion (approximately 30 minutes)

Effect of stent on ureteral peristalsis in non-stented ureter pre and post stenting

University of British Columbia

Associate Professor

Carcinoma

Carcinoma, Transitional Cell

Urethral Neoplasms

Ureteral Neoplasms

Pelvic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urethral Diseases

Ureteral Diseases

Transitional Cell Carcinoma

Urethral Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Cisplatin

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Tremelimumab

Ipilimumab

Antineoplastic Agents, Immunological

Immunologic Factors

Immune Checkpoint Inhibitors

Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.

Undergo cystectomy with pelvic lymph node dissection

Therapeutic Conventional Surgery

Jianjun Gao

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

SECONDARY OBJECTIVES:

I. To assess immunologic/molecular responses (e.g. peripheral blood cluster of differentiation \[CD\] 4+inducible T-cell co-stimulator \[ICOS\]+ T cells) to durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

II. To evaluate pathologic T0 rate after neoadjuvant treatment with durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer comparing to historical data (about 10% in patients with high-risk disease).

III. To evaluate relapse-free survival (RFS) and overall survival (OS).

OUTLINE:

Patients receive tremelimumab intravenously (IV) over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.

After completion of study treatment, patients are followed up at 90 days, and then every 3 months for up 1 year.

Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab) Plus Anti-CTLA-4 (Tremelimumab) in Patients With Muscle-Invasive, High-Risk Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Neoadjuvant Chemotherapy

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)	NCT04869462	Prostate Cancer Kidney Cancer Congenital Abno... Nephrolithiasis Kidney Tubercul... Nephritis Kidney Injury Hydronephrosis		18 Years -	Aesculap AG
The Impact of Ureteral Stents on Peristalsis	NCT01739738	Kidney Stones Tumor Hydronephrosis	Ureteral Stent	19 Years -	University of British Columbia
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery	NCT02812420	Hydronephrosis Infiltrating Bl... Infiltrating Bl... Infiltrating Bl... Infiltrating Re... Renal Pelvis Ur... Stage II Bladde... Stage II Renal ... Stage II Ureter... Stage II Urethr... Stage III Bladd... Stage III Renal... Stage III Urete... Stage III Ureth... Stage IV Renal ... Stage IV Ureter... Stage IV Urethr... Ureter Urotheli... Urethral Urothe...	Durvalumab Therapeutic Con... Tremelimumab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hydronephrosis