Clinical trials: sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Funder type Industry (pharma, biotech, devices)
Dialysis
Study of 3D Ultrasound for Support of Hemodialysis Cannulation
This study is a prospective, single arm, multi-center two-stage feasibility study designed to evaluate the safety and effectiveness of the use of the EchoMap device to assist in traditional methods of AV fistula cannulation.
- Trial name
- NCT07891741
- Testing
- EchoMap, Standard of Care Cannulation
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sonavex, Inc.
Urologic Diseases, Urodynamics
Trial for Reliability of Urodynamics SysTem
The goal of this prospective trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms.
- Trial name
- TRUST-1 (NCT05694793)
- Testing
- Glean Urodynamics System
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Bright Uro
GERD, Acid Reflux, Treatment
Omega Cuff for GERD Feasibility Study
This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period.
- Trial name
- NCT04793035
- Testing
- Omega-Cuff
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Aplos Medical
Type 1 Diabetes, Type 2 Diabetes
Closed Loop Glucose Control in a Simulated ICU Setting
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Stress Induced Hyperglycemia
- Trial name
- NCT07646067
- Testing
- FUSION closed loop glucose control system
- Volunteers
- 6 people
- Sponsor
- Ideal Medical Technologies
Renal Calculi, Urinary Calculi
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology.
- Trial name
- NCT03811171
- Testing
- Break Wave extracorporeal lithotripsy
- Where
- 6 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- SonoMotion
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
- Trial name
- NCT05680233
- Testing
- OA-235i (4 mg), OA-235i (8 mg), OA-235i (16 mg)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oasis Pharmaceuticals, LLC
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Safety Issues
A Phase 1 Study of EXT608 in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants.
- Trial name
- NCT05408663
- Testing
- EXT608
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Extend Biosciences Inc.
Celiac Disease
Study of Latiglutenase in T1D/CD Patients
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.
- Trial name
- NCT04839575
- Testing
- Latiglutenase
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Entero Therapeutics
Painful Diabetic Neuropathy, Diabetes Mellitus
A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy
This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects with Type II Diabetes and painful peripheral neuropathy.
- Trial name
- NCT04786340
- Testing
- Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- WinSanTor, Inc
Neurogenic Bladder, Urinary Retention
Connected Catheter - Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Neurogenic Bladder, Urinary Retention, Urologic Diseases
- Trial name
- NCT04059159
- Testing
- Connected Catheter
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Spinal Singularity
Diabetes Mellitus, Type 1, Type 1 Diabetes
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer…
- Trial name
- NCT04398030
- Testing
- coil-reinforced soft polymer indwelling cannula, soft Teflon indwelling catheter
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Capillary Biomedical, Inc.
Overactive Bladder
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
- Trial name
- NCT04115228
- Testing
- Implantation and neuromodulation therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nine Continents Medical, Inc.
Benign Renal Tumors, Malignant Renal Tumors
First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy
The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint profile of laser tissue welding therapy for sealing the resected kidney surface after laparoscopic partial nephrectomy required for…
- Trial name
- LTW-KIDNEY (NCT02061605)
- Testing
- Laser Tissue Welding Device
- Where
- United States
- Sponsor
- Laser Tissue Welding, Inc.
GI Carcinoma, GI Disorders
Phase 2 Study of NX9 for Delineation of Bowel Anatomy
This study will evaluate marking and distention of the bowel of the oral contrast agent, NX9, at CT of the abdomen and pelvis, VLDCT with no contrast will be followed by VLDCT with NX9 contrast followed by CT with NX9 and…
- Trial name
- NCT04789200
- Testing
- NX9 Oral Contrast Agent
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Nextrast, Inc.
Iron Deficiency
Safety and Tolerability of BioFe for Iron Deficiency Management
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.
- Trial name
- NCT03484026
- Testing
- BioFe
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sidero Bioscience, LLC
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes, Diabetic Foot Ulcer
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU).
- Conditions
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- Trial name
- NCT02657876
- Testing
- ExpressGraft-C9T1 Skin Tissue
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Glucose, Low Blood, Glucose, High Blood
Dose Safety Hybrid Closed Loop and Fully Automated Closed Loop Artificial Pancreas Device in CRC
The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a population of subjects with type 1…
- Trial name
- NCT03428295
- Testing
- Dose Safety AP system
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Dose Safety Inc.