Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Hypertrophy

Prostatic Hyperplasia

Urinary Bladder Calculi

Kidney Calculi

Calculi

Nephrolithiasis

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Kidney Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Urinary Bladder Diseases

Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.

comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP).

Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.

NV-VPAC1 PCa Urine Diagnostic Test

Jay Bishoff, MD

This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.

Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones

Degree of association of the presence of orange fluorescent positive cells shed in voided urine of men with biopsy-proven PCa and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones

NuView Diagnostics

Intermountain Health Care, Inc.

Director of Intermountain Urological Institute

Neoplasm Metastasis

Hyperoxaluria

Neoplastic Processes

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

Hydronephrosis

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

Infections

Digestive System Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Communicable Diseases

Intestinal Diseases

Aneurysm

Vascular Diseases

Leiomyoma

Aortic Aneurysm

Gastrointestinal Diseases

Myofibroma

Diverticulitis

Pregnancy, Ectopic

Pancreatitis

Intraabdominal Infections

Gallstones

Cholelithiasis

Cholecystolithiasis

Cysts

Ovarian Cysts

Polyps

Appendicitis

Cardiac Complexes, Premature

Abdominal Injuries

Pancreatic Diseases

Aortic Diseases

Gastroenteritis

Cecal Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Diverticulum

Diverticular Diseases

Biliary Tract Diseases

Gallbladder Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Gonadal Disorders

Endocrine System Diseases

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Joshua Broder, MD

Summary

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis.
2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications

Wallace H. Coulter Foundation

Duke University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.	NCT03630926	Prostate Cancer Benign Prostati... Bladder Stones Kidney Stones	NV-VPAC1 PCa Ur...	18 Years - 80 Years	Intermountain Health Care, Inc.
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
The Impact of Ureteral Stents on Peristalsis	NCT01739738	Kidney Stones Tumor Hydronephrosis	Ureteral Stent	19 Years -	University of British Columbia
Point of Care 3D Ultrasound for Various Applications: A Pilot Study	NCT02831556	Appendicitis Evidence of Cho... Gallstones Pregnancy, Ecto... Aortic Aneurysm Kidney Stones Intrauterine Pr... Diverticulitis Abdominal Injur... Tumors Pancreatitis Digestive Syste... Gastrointestina... Intraabdominal ... Intestinal Dise... Pregnancy Vascular Diseas... Uterine Fibroid... Ovarian Cysts Uterine Abnomin... Bladder Abnomin... Testicular Abno... Polyps		-	Duke University

Spots Global Cancer Trial Database for kidney stones