Clinical trials: Safety and Usability
Spinal Cord Injuries
Clinical Investigation on the Impact on Safety, Feasibility and Usability of the Design Changes Performed on ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians.
- Trial name
- NCT05590065
- Testing
- ABLE Exoskeleton
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- ABLE Human Motion S.L.
Diabetes Mellitus, Type 1
MiniMed™ 670G System China Study for Type I Diabetic
The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China.
- Trial name
- NCT04663295
- Testing
- MiniMed™ 670G system
- Where
- 4 sites in China
- Volunteers
- 74 people
- Sponsor
- Medtronic MiniMed, Inc.
Overactive Bladder
Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects
The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder.
- Trial name
- XAVIER (NCT06345677)
- Testing
- ViXe Xombination
- Where
- 8 sites in Portugal
- Volunteers
- 48 people
- Sponsor
- Vensica Therapeutics Ltd.
IUD Insertion
Usability, Safety and Efficacy of AspivixTM (Comparative Study)
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).
- Trial name
- NCT04441281
- Testing
- Traction of the cervix for IUD insertion
- Where
- 2 sites in Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Aspivix SA
Feeding Tube, Dysphagia
Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device
A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device on 20 adult patients with a need for enteral feeding.
- Trial name
- Fidmi (NCT03007511)
- Testing
- Fidmi enhanced enteral feeding device
- Where
- 2 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Fidmi Medical
Healthy Volunteer
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants
This study is a multi-center, single-arm, open-label study in healthy participants to assess the pain, tolerability, injection leakage, safety, and usability of a single self-administered subcutaneous (SC) dose of etrolizumab.
- Trial name
- NCT02629744
- Testing
- Etrolizumab, Prefilled Auto-injector (Rotaject)
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Androgenic Alopecia
Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia
The CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events.
- Trial name
- NCT05611593
- Testing
- FOL100, Propecia 1Mg Tablet
- Where
- 3 sites in Israel
- Volunteers
- 90 people
- Sponsor
- Follicle Pharma Ltd
ESRD, Hemodialysis
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study…
- Trial name
- NCT04868643
- Testing
- The DIMI Renal Replacement Therapy (RRT) System
- Sponsor
- Dialco Medical Inc.
Spinal Cord Injuries, Gait Disorders, Neurologic
Safety and Feasibility of TWIICE Rise - Phase 2
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.
- Trial name
- NCT07461259
- Testing
- TWIICE Rise
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- TWIICE
Heart Failure
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
- Trial name
- NCT06147336
- Testing
- V-LAP™ SYSTEM
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Chronic Kidney Disease Stage 5
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days.
- Trial name
- NCT04808011
- Testing
- Intelligent Dialysis Assistant (IDA)
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- liberDi Ltd.
Safety and Usability
The Stork OTC: Collection, Placement & Delivery
This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the…
- Trial name
- NCT02038322
- Testing
- The Stork - Conception Aid
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Rinovum Women's Health, Inc.