Clinical trials: Safety and Performance
Pregnancy
Safety and Performance of a Fetal Monitoring System
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
- Trial name
- M•CARE SE (NCT05294211)
- Testing
- M•care™ System, Cardiotocography (CTG)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Marani Health
Coronary Vessel Occlusion
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion…
- Trial name
- NCT03957473
- Testing
- Indigo Aspiration System
- Where
- 25 sites in United States
- Volunteers
- 400 people
- Sponsor
- Penumbra Inc.
Diabetic Foot Ulcers
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
- Trial name
- CHEXU 01 (NCT02091778)
- Testing
- Fast gelling dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Acetabulum Fracture, Pelvic Ring Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System…
- Trial name
- NCT05215626
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Zimmer Biomet
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Glaucoma, Glaucoma, Open Angle
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
- Trial name
- NCT02036541
- Testing
- AqueSys XEN 45 Glaucoma Implant
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- AqueSys, Inc.
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Primary Open-angle Glaucoma
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)
- Trial name
- NCT03651336
- Testing
- ARGOS-IO Sensor Pressure System
- Where
- 4 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Arrhythmia
Perclose Multi-Access Duplex Ultrasound (DUS) Study
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and…
- Trial name
- NCT04904809
- Testing
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Abbott Medical Devices
Benign Prostatic Hyperplasia (BPH)
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
- Trial name
- NCT04823221
- Testing
- Rezūm System
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Boston Scientific Corporation
Polyp of Colon, Endoscopic Mucosal Resection
EndoRotor® Endoscopic Mucosal Resection System for the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic…
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- Trial name
- NCT04203667
- Testing
- EndoRotor Resection
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 66 people
- Sponsor
- Interscope, Inc.
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.
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Benign Gallbladder Disease
Levita Magnetic Grasper Device Safety and Performance Study
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
- Trial name
- NCT02049983
- Testing
- Use of Levita Magnetics Grasper
- Where
- 3 sites in Chile
- Volunteers
- 50 people
- Sponsor
- Levita Magnetics
Transcatheter Aortic Valve Replacement
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high…
- Trial name
- NCT01627691
- Testing
- Lotus Valve System
- Where
- 20 sites in Australia, France and 7 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Refractive Errors
Safety and Effectiveness of the Qualis Contact Lens
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
- Trial name
- NCT04295499
- Testing
- soft (hydrophilic) contact lens
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Unicon Optical Co. Ltd.
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Obstructive Sleep Apnea
A Phase II Pilot Study of the Trillium Full Face Mask
This will be a single-center, open-label randomized crossover design pilot study to evaluate the clinical safety, clinical performance, and clinical benefit of the Trillium full face mask
- Trial name
- NCT06932055
- Testing
- Trillium Full Face Mask, AirFit F20
- Volunteers
- 40 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.