Clinical trials: Safety and Performance
Colorectal Cancer
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
- Trial name
- NCT06540807
- Testing
- Colovac Colorectal Anastomosis Protection Device, Stoma creation
- Where
- Uzbekistan
- Volunteers
- 24 people
- Sponsor
- SafeHeal Inc
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Behavior
RxConnect User Testing Study
Background Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically…
- Trial name
- NCT05493072
- Testing
- RxConnect
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Carcinoma, Hepatocellular, Liver Metastases
Study to Evaluate VORTX Rx (Theresa)
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors
- Trial name
- Theresa (NCT03741088)
- Testing
- VORTX Rx treatment
- Where
- 3 sites in Spain
- Volunteers
- 8 people
- Sponsor
- HistoSonics, Inc.
Amputation of Lower Limb
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated.
- Trial name
- NCT06938087
- Testing
- 3D printed prosthesis foot, Current prosthesis foot
- Where
- Italy
- Volunteers
- 3 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Meniscus Tear, Knee Meniscus Injury
High-Purity Type I Collagen Augmentation in Meniscal Repair
This prospective, single-arm feasibility study evaluates the safety, procedural feasibility, and early clinical outcomes of High-Purity Type I Collagen used as an adjunct in arthroscopic meniscal repair.
- Conditions
- Meniscus Tear, Knee Meniscus Injury, Meniscal Repair, Knee Arthroscopy (for Diagnostic or Therapy)
- Trial name
- NCT07352410
- Testing
- High-Purity Type I Collagen
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Subjects With an Ileostomy
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
- Trial name
- NCT01800890
- Testing
- Coloplast A, Coloplast B, Coloplast C
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Lung Cancer
EPIONE Guided Lung Evaluation
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
- Trial name
- EGLE (NCT05651867)
- Testing
- EPIONE device
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Quantum Surgical
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.
Lung Cancer
Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear…
- Trial name
- NCT05329402
- Testing
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler, ECHELON Flex Powered Articulating Endoscopic Linear Cutters
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Fengh Medical Co., Ltd.
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Mitral Valve Regurgitation, Mitral Regurgitation
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the…
- Trial name
- NCT03502811
- Testing
- MitraClip NTR/XTR System
- Where
- 57 sites in United States, Germany and 6 more
- Volunteers
- 1,041 people
- Sponsor
- Abbott Medical Devices
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear