Clinical trials: Safety and Usability
Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema
Ocular Safety and Usability Study for FYB201 PFS
The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema
- Trial name
- NCT06708624
- Testing
- FYB201 0.5 mg (0.05 mL of 10 mg/mL)
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Formycon AG
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
IUD Insertion
Usability, Safety and Efficacy of AspivixTM
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
- NCT04441333
- Testing
- AspivixTM cervical vacuum tenaculum
- Where
- Switzerland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Aspivix SA
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.
Venous Leg Ulcer, Venous Insufficiency of Leg
Preliminary Investigation of a Smart Compression Therapy Prototype
Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits.
- Trial name
- PRESUF-VLU (NCT05610241)
- Testing
- Compression Therapy System Prototype, Standard Compression
- Where
- Ireland
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Type 2 Diabetes
Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
- Trial name
- NCT01932775
- Testing
- GlucoTab System
- Where
- Austria
- Volunteers
- 99 people
- Sponsor
- Medical University of Graz
Atrial Fibrillation
Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
Voice Assist Arrhythmia Monitoring (VAAM) is an application running on smartphones and/or landline phones that performs vocal tests for the monitoring of abnormalities in the heart rhythm.
- Trial name
- NCT04613544
- Testing
- Voice Assist Arrhythmia Monitoring (VAAM)
- Where
- 2 sites in Israel
- Volunteers
- 400 people
- Sponsor
- Cardiokol Ltd
Chronic Heart Failure, Edema
AquaPass Device in Treatment of CHF Patients
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
- Conditions
- Chronic Heart Failure, Edema, CHF
- Trial name
- NCT05843201
- Testing
- The AquaPass System
- Where
- 2 sites in Israel
- Volunteers
- 18 people
- Sponsor
- AquaPass Medical Ltd.
Children Under 18 Years Old With Kidney Disease
Study of FFI-1010 in Pediatric Kidney Disease
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
- Trial name
- NCT03345316
- Testing
- FFI-1010
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Fuji Yakuhin Co., Ltd.
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Colo-rectal Cancer
Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center…
- Trial name
- C-Scan (NCT03735407)
- Testing
- C-Scan procedure
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Check-Cap Ltd.
Spinal Cord Injuries, Gait Disorders, Neurologic
Safety and Feasibility of TWIICE Rise
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
- NCT05926310
- Testing
- TWIICE Rise
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- TWIICE
Reduction of Postoperative Adhesions
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy.
- Trial name
- NCT03820713
- Testing
- Concentrate of plasma coagulation factors, 0.9% saline
- Where
- 2 sites in Lithuania
- Volunteers
- 30 people
- Sponsor
- Eio Biomedical Ltd.
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.
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.
Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema
Ocular Safety and Usability Study for FYB203 PFS
The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema, Diabetic Macular Edema
- Trial name
- NCT06708637
- Testing
- FYB203 2 mg (0.05 mL of 40 mg/mL)
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Formycon AG
Hypogonadism
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
- Trial name
- NCT02777242
- Testing
- Testosterone enanthate auto-injector
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Antares Pharma Inc.
Heart Failure
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
- Trial name
- VECTOR-HF (NCT03775161)
- Testing
- V-LAP™ System
- Where
- 2 sites in Germany, Italy
- Volunteers
- 45 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Safety and Usability
Béa Applicator and Béa Cervical Cap Safety and Usability Study
This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.
- Trial name
- NCT05129553
- Testing
- Béa Applicator and Béa Cervical Cap Device
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- StepOne Fertility
Spinal Cord Injury (SCI)
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal…
- Trial name
- NCT06772077
- Testing
- Rehabilitation treatment with ATLAS2030
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- MarsiBionics