Clinical trials: Safety and Performance
VF, VT
Defibrio AED Study
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator). The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to…
- Trial name
- NCT07880873
- Testing
- treatment with Defibrio AED
- Volunteers
- 25 people
- Sponsor
- Defibrio, LLC
Paroxysmal Atrial Fibrillation
Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- QDOT-FAST (NCT03459196)
- Testing
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 54 people
- Sponsor
- Biosense Webster, Inc.
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical
Abdominal Aortic Aneurysm
TriVascular Post-Market Registry
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the…
- Trial name
- NCT01372709
- Testing
- Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- Where
- 30 sites in Austria, Belgium and 6 more
- Volunteers
- 501 people
- Sponsor
- TriVascular, Inc.
Ileostomy - Stoma
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
- Trial name
- NCT01994863
- Testing
- Coloplast Test product, Standard Care
- Where
- Netherlands
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S
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
Prolapse; Female
Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.
An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).
- Trial name
- SCUPP (NCT06620211)
- Testing
- promontofixation, prolapse cure
- Where
- France
- Volunteers
- 290 people
- Sponsor
- Cousin Biotech
Humeral Fractures, Proximal, Humeral Fractures
Affixus Natural Nail System Humeral Nail PMCF
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and…
- Trial name
- NCT05019664
- Testing
- humeral fracture
- Where
- 5 sites in United States, Belgium and 2 more
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Dry Eye Syndromes
Efficacy of T2259 in DED
The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.
- Trial name
- NCT03874429
- Testing
- T2259, Vismed multi
- Where
- France
- Volunteers
- 101 people
- Sponsor
- Laboratoires Thea
Benign Prostatic Hyperplasia
The Zenflow Spring System Safety and Performance Study (ZEST CAN)
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
- Trial name
- NCT04309695
- Testing
- Zenflow Spring System
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Zenflow, Inc.
Performance and Safety
Clinical Study of CT 5400 RT for System Validation
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Trial name
- NCT06466577
- Testing
- CT 5400 RT System
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, 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 DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Colorectal Anastomosis, Left-sided Colon Resection
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in…
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication
- Trial name
- SECURE (NCT07351071)
- Testing
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Where
- 10 sites in United States
- Volunteers
- 137 people
- Sponsor
- Medtronic - MITG
Atrial Fibrillation
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
- Trial name
- GPS-CA (NCT04486924)
- Testing
- Globe Mapping and Ablation System
- Where
- 2 sites in Canada
- Volunteers
- 18 people
- Sponsor
- Kardium Inc.
Vulvovaginal Atrophy
Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy
This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and…
- Trial name
- NCT03725410
- Testing
- Venus Fiore Study Treatment
- Where
- 2 sites in Italy, Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- PROTONTO (NCT04542577)
- Where
- 2 sites in Germany
- Volunteers
- 208 people
- Sponsor
- Aesculap AG
Knee Osteoarthritis (Knee OA)
Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200
Study in patients with knee osteoarthritis treated by embolization using NBGM200
- Trial name
- NCT06930677
- Testing
- embolization therapy
- Where
- 3 sites in Belgium, Netherlands
- Volunteers
- 72 people
- Sponsor
- Next Biomedical Co., Ltd.
Bone Fractures, Bone Defects
Study on Safety and Performance of AdvanCore Bone Void Filler
The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and…
- Conditions
- Bone Fractures, Bone Defects, Bone Loss, Bone Graft
- Trial name
- NCT06736457
- Testing
- AdvanCore bone grafting
- Where
- 4 sites in Portugal
- Volunteers
- 190 people
- Sponsor
- Artur Salgado SA
Abdominal Aortic Aneurysm (AAA)
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02009644
- Testing
- Subjects who receive the Treovance stent-graft
- Where
- 29 sites in United States
- Volunteers
- 158 people
- Sponsor
- Bolton Medical
Knee Osteoarthristis
New Treatment of Knee Osteoarthritis
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and…
- Trial name
- PIVHAC (NCT06611098)
- Testing
- Viscosupplements
- Where
- 2 sites in Georgia, Latvia
- Volunteers
- 134 people
- Sponsor
- Symatese
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