Clinical trials: Safety and Usability
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
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.
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.
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
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
Incontinence, Urge
T-DOC® NXT Clinical Investigation
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
- Trial name
- NCT03615001
- Testing
- TDOC NXT
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Oncology, Adherence, Medication
Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics
In recent decades, an increasing number of oral anticancer medications (oral oncolytics) have been approved. Oral oncolytics now make up to 30% of the oncology market, and their use is continually expanding.
- Conditions
- Oncology, Adherence, Medication, Side Effect
- Trial name
- NCT04091711
- Testing
- ReX-C system
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Dosentrx Ltd.
Stroke
Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation
The study aims to assess the feasibility of using Resynk, a virtual reality (VR) software platform for upper limb rehabilitation for stroke survivors, both in acute hospital settings and in the community (home, private nursing…
- Trial name
- NCT07032155
- Testing
- Resynk VR session, Using Resynk VR on stroke survivors
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- eXRt Intelligent Healthcare
Non-muscle-invasive Bladder Cancer
T-Control® Safety for Cytostatics Management
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the…
- Trial name
- NCT06678633
- Testing
- T-Control® (experimental), Folysil® (control)
- Volunteers
- 16 people
- Sponsor
- Rethink Medical SL
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.
Ankle Sprains, Lateral Ankle Sprain
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
The goal of this study is to learn whether a 28-day home exercise program using the AxisBoard Single-Leg Balance Board improves ankle function in adults who are still having symptoms 6 weeks to 6 months after a lateral (outer)…
- Trial name
- NCT07860125
- Testing
- AxisBoard Single-Leg Balance Board
- Volunteers
- 80 people
- Sponsor
- DITU Inc.
Social Phobia
Pilot Study: VR Mind and VR Mind+ Intervention
The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be: the length of the laboratory session utilizing virtual reality exposure…
- Trial name
- NCT03647605
- Testing
- VR Mind
- Where
- Poland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tomorrow Sp. z o.o.
Atrial Flutter
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
- Trial name
- NCT02768051
- Testing
- AF Ablation
- Sponsor
- EPD Solutions, A Philips Company
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.
Heart Failure
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF
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
- NCT05712824
- Testing
- V-LAP™ SYSTEM
- Where
- 3 sites in Georgia
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Diffuse Large B Cell Lymphoma, Multiple Myeloma
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
- Trial name
- PC002 (NCT06323447)
- Testing
- PointCheck
- Where
- 6 sites in United States, Spain
- Volunteers
- 210 people
- Sponsor
- Leuko Labs, Inc.
Hemostasis, Distal Radial Artery Access (dTRA)
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
This clinical study has been organised to learn more about the safety and use of the TR Band Distal device in patients who have had a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal…
- Trial name
- EASY DISTAL (NCT07888738)
- Testing
- TR Band Distal
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 320 people
- Sponsor
- Terumo Europe N.V.
Total Knee Arthroplasty
MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention
The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA).
- Trial name
- NCT05544409
- Testing
- MAKv1
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- MarsiBionics
Spinal Cord Injury, Acquired Brain Injury
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modular technology for gait…
- Trial name
- NCT05265377
- Testing
- Stelo
- Where
- 3 sites in Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion