Clinical trials: Safety and Usability
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
Moderate to Severe Plaque-type Psoriasis
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- FEATURE (NCT01555125)
- Testing
- secukinumab 150 mg, secukinumab 300 mg
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
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.
Parkinson Disease (PD)
Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
- Trial name
- NCT07284823
- Testing
- Cionic Neural Sleeve Multistim System
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cionic, Inc.
Natural Conception, Label Comprehension
FERTI-LILY Safety Study
The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup.
- Conditions
- Natural Conception, Label Comprehension, Device Usability, Safety Issues
- Trial name
- NCT05529160
- Testing
- FERTI LILY Conception Cup
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Rosesta Medical BV
Ultrasonography, Prenatal
Instinct™ Ultrasound Device Safety, Efficacy and Usability
Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone…
- Trial name
- NCT04399408
- Testing
- Obstetrics Ultrasound (non invasive)
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PulseNmore
Spinal Cord Injury Cervical
UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
- Trial name
- UPNRIDE_SAFE (NCT02983955)
- Testing
- UPnRIDE Powered Wheelchair
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- UPnRIDE Robotics Ltd.
Stroke, Gait, Hemiplegic
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the…
- Trial name
- NCT04837144
- Testing
- Physical Rehabilitation with MAK exoskeleton
- 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
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.
Spinal Cord Injuries
Clinical Investigation on Safety, Feasibility and Usability of the 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
- NCT04876794
- Testing
- ABLE Exoskeleton
- Where
- 2 sites in Germany, Spain
- Volunteers
- 24 people
- Sponsor
- ABLE Human Motion S.L.
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.
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.
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as…
- Trial name
- NCT01678482
- Testing
- light based device for treatment of acne
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Home Skinovations Ltd.
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
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
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.
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
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.
Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO
A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema
This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar).
- Conditions
- Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema
- Trial name
- NCT07844343
- Testing
- SB15 PFS
- Where
- 3 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Samsung Bioepis Co., Ltd.