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

Neoplasm Metastasis

Hyperoxaluria

Neoplastic Processes

Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period.

Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period

Lanthanum Carbonate

Celine Olbrechts, Study Coordinator

Els Van de Perre, MD

Celine Olbrechts

Christian Tielemans, MD, PhD

This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.

Nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in Western countries) and highly recurrent disease. Secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. Currently used therapeutic options in secondary hyperoxaluria have limited efficacy. Recent findings in vitro and in a rat model, provided evidence that Lanthanum Carbonate is an effective oxalate binder. The objective of this study is to investigate whether treatment with Lanthanum Carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. By treating the patients with two different doses of Lanthanum Carbonate during two 14-day treatment periods, a dose-response will be evaluated.

This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis. Patients will be treated during 2 consecutive 14-day treatment periods with a low and a high dose of Lanthanum Carbonate respectively.

Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis

Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis: a Short-term, Prospective, Open-label, Efficacy and Safety Clinical Trial

Mean reduction in urinary oxalate excretion after the first 14-day treatment period during which patients will be treated with 250 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine.

Incremental reduction of mean urinary oxalate excretion after the second 14-day treatment period during which the patients will be treated with 500 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine

Severe hypophosphatemia is defined as serum phosphorus \< 0.64 mmol/L

24-hour urinary phosphorus excretion will be expressed in mmol/24 hours

Urinary phosphorus to creatinine ratio will be expressed in mmol phosphorus/g creatinine

Fractional excretion of phosphorus will be expressed in %, defined as (urinary phosphorus (mmol/L) x serum creatinine (mg/dL) / (serum phosphorus (mmol/L) x urine creatinine (mg/dL))

Hypophosphaturia is defined as urinary phosphorus \< 12.9 mmol/24 hours

24-hour urinary calcium excretion will be expressed in mmol/24 hours

Urinary calcium to creatinine ratio will be expressed in mmol calcium/g creatinine

Fractional excretion of calcium will be expressed in %, defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium (mmol/L) x urine creatinine (mg/dL))

Serum Lanthanum levels will be expressed in mcg/L

The number and the proportion of patients experiencing adverse events

Universitair Ziekenhuis Brussel

Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals

Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals

ALLN-177 7,500 units (5 capsules) PO TID with meals

ALLN-177

Placebo

Annamaria Kausz, MD MS

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Allena Pharmaceuticals

Test Meal

Annamaria Kausz, MD, MS

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4).

Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal.

Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Percent of oxalate absorption normalized by baseline was calculated by 100\*\[UOx/test - UOx/baseline\]/Ox intake from the test meal.

Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.

Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 \* \[UOx/Cr for the test interval - UOx/Cr at Baseline\] / UOx/Cr at Baseline.

Since no investigational product was administered; no drug-related adverse events (AEs) occurred. The investigator assessed AEs by intensity (severity) and causality in relation to the study intervention, which was the study diet. Any untoward symptoms or worsening of medical conditions reported during the study were recorded as AEs.

The Enrolled Set included all subjects who were determined to be eligible for the study after screening assessments and were enrolled in the study.

Enrolled Set

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

BMI (kg/m^2)

Estimated glomerular filtration rate

Hyperoxaluria Classification

Number of Kidney Stone Episodes at Study Entry

Allena Medical Affairs

Enrolled set which included all enrolled subjects

Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period

0-4 Hours post test meal

0-6 hours post test meal

0-24 hours post test meal

Percent of Oxalate Absorption By Test Interval

0-4 hours post test meal

6-24 hours post test meal

Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval

Overall Study

Ureteral Neoplasms

Ureteral Diseases

telerounding versus bedside rounding

Lars Ellison, MD

Telerounding is the use of wireless remote video-confrencing to assess hospitalized patients. Physicians thus rely on all ususal data collected during bedside rounds with the exeption of a direct physical exam. The intention of this study is to determine if post-operative morbidity can be identified in an accurate and timely manner.

Design: Two hundred seventy patients were recruited from three sites into a prospective multi-center randomized trial. Participating institutions were the University of California, Davis Medical Center (Sacramento CA), Johns Hopkins Hospital (Baltimore MD) and Sentara Health (Norfolk VA). Internal Review Board approval was granted at each institution independently. The study population consisted of patients scheduled for urologic surgery, over age 18, and able to read and understand English. Patients undergoing the following laparoscopic procedures were offered participation: nephrectomy, partial nephrectomy, nephroureterectomy, retroperitoneal lymph node dissection, partial ureterectomy, and radical prostatectomy. Patients had an expected hospital stay of 24 to 72 hours. Eligible patients who were unable to provide consent or who do not wish to participate in the study received the standard of care provided at each institution. A total of two hundred seventy patients consented to participation.

Randomization: A stratified block scheme was used for randomization. Participating patients were randomized to either: standard daily bedside rounding by the attending surgeon (control arm), or daily telerounding only by the attending surgeon (intervention arm).

Outcome Measures: The primary outcome measure was differences in rates of attending surgeon-identified complications between standard rounds and telerounds. The secondary outcome measures included differences in length of stay and patient reported satisfaction with their hospitalization.

Protocol: Consenting patients had their scheduled surgery and received the standard peri-operative and immediate post-operative care. All patients were managed with a rapid recovery protocol. This included: liquid diet beginning twelve hours after surgery with immediate advancement as tolerated; complete blood count, serum electrolytes, BUN and creatnine in the recovery room and each morning until discharge; and usual nursing data recorded each shift. These data points included oral temperature, blood pressure, pulse, respiratory rate, fluid intake, fluid output, and pain scale Once transferred to the patient floor, all patients communicated with their attending physician on a daily basis. The visit, either at the bedside or via telerounds followed a set scripting. The visit was conducted between the patient and the attending without other staff present. The focus of the visit was review of objective data (vital signs, fluid balances and laboratory values), subjective data (cursory abdominal exam if at the bedside and evaluation of drain effluent) and a discussion of the anticipated goals for the day. Visit duration was timed. Intervention patients could remove themselves from the study at any time by requesting a bedside visit by the attending physician. Telerounding concluded with either the hospital discharge or identification of a major post-operative complication.

Definitions: A major complication was defined as an event that required transfer to a monitored setting. Minor complications included events that delay discharge greater than 24 hours beyond the expected length of stay. For example (but not limited to): post-operative ileus, drop in hematocrit, prolonged drain output or fever Event monitoring: Identification of complications was recorded prospectively. Usual resident-level bedside rounds were maintained throughout the study. The resident team and the attending surgeon recorded identified events independently, thus allowing for evaluation of concordance. This dual rounding design served as a minimally acceptable standard as stipulated by the various internal review boards. As a precondition of IRB approval, identification of an event required notification of the attending surgeon in a timely fashion.

Instrument: We utilized a validated 21-item questionnaire to evaluate patient ratings of their hospital care. Items regarding postoperative care were designed using an extensively tested and validated response scale (1, poor to 5, excellent). Item stems were modified from Patient Judgments of Hospital Quality to make them more salient to the postoperative experience. Five items asked patients to rate their baseline health status as well as their health status during the hospitalization. Seven items asked patients to evaluate aspects of the care they received while an in-patient. Nine items asked those randomized to the telerounding arm to evaluate the telecommunications system and to indicate their level of interest in having this system incorporated into usual post-operative care.

Device: The telerounding robot is a 60-inch tall wheel driven device. The robot consists of the motor base unit, Pentium III CPU, high definition digital camera, flat screen monitor and microphone. Data to and from the robot is transferred over a high-speed wireless network and integrated with proprietary software. The physician connects remotely to the robot via a base station. The base station consists of a Pentium III desktop computer, high definition digital camera, flat screen monitor, microphone and joystick controller. Each of the institutions used identical technology. Prior testing of the system demonstrated imperceptible video and audio delay.

Analytic Plan: The primary endpoint of the study is patient morbidity. The expected rate of complication (major and minor) after a laparoscopic urologic procedure is 16%. Based on our power calculation, a total of 270 patients (135 in each arm) were required to detect a 1% difference in complication at the 0.05 alpha level and the 0.8 beta level. Continuous variables were compared using student T-test. Proportions were compared using chi-square analysis. Logistic regression was reserved for adjustments based on observed statistical differences in baseline demographic data.

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
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis	NCT03346369	Secondary Hyper... Nephrolithiasis	Lanthanum Carbo...	18 Years -	Universitair Ziekenhuis Brussel
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days	NCT02547805	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones Dietary Hyperox...	ALLN-177 Placebo	18 Years -	Allena Pharmaceuticals
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria	NCT03095885	Secondary Hyper... Nephrolithiasis Hyperoxaluria Kidney Stones	Test Meal	18 Years -	Allena Pharmaceuticals
Postoperative Telerounding: A Multi-Center Prospective Randomized Assessment of Patient Outcomes and Satisfaction.	NCT00263107	Kidney Cancer Ureteral Cancer Prostate Cancer Nephrolithiasis	telerounding ve...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for nephrolithiasis