Clinical trials: Performance and Safety
Cataract
Outcomes of Phacoemulsification With Torsional Ultrasound
To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or…
- Trial name
- NCT01010490
- Testing
- Torsional ultrasound (INFINITI, Alcon, USA), Longitudinal U/S (Infiniti system, Alcon, USA), Longitudinal U/S (LEGACY 20000, Alcon, USA)
- Where
- India
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Iladevi Cataract and IOL Research Center
Gastrointestinal Discomfort, Performance Status
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects.
- Trial name
- G3P-01-01 (NCT05296083)
- Testing
- G3P-01
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- SQ Innovation, Inc.
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Iliac Aneurysm, Aortic Aneurysm, Abdominal
iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
The goal of this clinical trial is to evaluate the safety, performance, and Preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adult patients requiring endovascular repair.
- Trial name
- TriHub (NCT07005141)
- Testing
- Endovascular Iliac Branch Stent-Graft Implantation
- Where
- 2 sites in Brazil
- Volunteers
- 10 people
- Sponsor
- Archo Medical S.A
Atrial Fibrillation
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF…
- Trial name
- DualSmart (NCT07845682)
- Testing
- Radiofrequency/Pulsed Field Ablation
- Volunteers
- 150 people
- Sponsor
- Biosense Webster, Inc.
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Peripheral Arterial Vascular Occlusion
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair…
- Trial name
- NCT00958230
- Testing
- dCell Vascular Patch
- Where
- 4 sites in Hungary, Netherlands
- Volunteers
- 21 people
- Sponsor
- Tissue Regenix Ltd
Aphakia, Astigmatism
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3…
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Trial name
- NCT06166901
- Testing
- AcrySof IQ PanOptix IOL Toric, AcrySof IQ PanOptix IOL Non-Toric
- Where
- 7 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Alcon Research
WOUNDS INJURIES
3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing…
- Trial name
- NCT05748392
- Testing
- Wound and per-wound assessments While using Device
- Where
- United States
- Sponsor
- Solventum US LLC
Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm…
- Trial name
- NCT06114992
- Testing
- Servo-n HFOV modes
- Where
- 4 sites in France, Poland and 1 more
- Volunteers
- 83 people
- Sponsor
- Maquet Critical Care AB
Type 1 Diabetes Mellitus
Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection
The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes.
- Trial name
- SPEED (NCT07679347)
- Testing
- CGM Devices
- Volunteers
- 20 people
- Sponsor
- SAVA Technologies Ltd.
Cataract, Presbyopia
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
- Trial name
- PSM15 (NCT02838004)
- Testing
- IOL MINI WELL READY
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- SIFI SpA
Left Atrial Appendage Aneurysm
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
This prospective, multi-center, non-randomized, single-blinded, open-label, single-arm, comparator study will enroll up to 100 eligible subjects from multiple sites undergoing LAAC procedure to evaluate the safety and performance…
- Trial name
- NCT05155943
- Testing
- KALPA X™
- Where
- 2 sites in Italy, Lithuania
- Volunteers
- 18 people
- Sponsor
- Cara Medical Ltd
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Mitral Regurgitation
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral…
- Trial name
- HRT (NCT03511716)
- Testing
- HRT Mitral Bridge Mitral Valve Repair
- Where
- Czechia
- Volunteers
- 34 people
- Sponsor
- Heart Repair Technologies, Inc.
Diabetes Mellitus, Type 2
Safety and Performance of the Glyconics-SX System (ANODE02)
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or…
- Trial name
- ANODE02 (NCT05476016)
- Testing
- Near-infrared (NIR)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
Rotator Cuff Tears of the Shoulder, Labrum Injury
Lok™ Suture Anchors Safety & Performance Trial
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation).
- Trial name
- NCT07448584
- Testing
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair
- Where
- France
- Volunteers
- 216 people
- Sponsor
- Move Up SAS
Acne Vulgaris, Folliculitis
Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis
The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, and folliculitis, will Ialuxid® Gel (hydrogen peroxide, hyaluronic acid and glycine) improve the course of…
- Trial name
- NCT05345093
- Testing
- Ialuxid gel
- Where
- Romania
- Volunteers
- 66 people
- Sponsor
- BMG Pharma
Soft Tissue Surgeries
A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
- Trial name
- MARS (NCT06974955)
- Where
- India
- Volunteers
- 365 people
- Sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.
Atrial Fibrillation
Safety & Performance of the Centauri System for Patients With Atrial Fibrillation
This is a prospective, single-arm, open-label clinical study following patients to 1 year, to evaluate the safety and performance of the Centauri system for catheter ablation of atrial fibrillation (AF).
- Trial name
- SPACE AF (NCT04652778)
- Testing
- Pulsed Field Ablation (PFA) using the Centauri System
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Galaxy Medical, Inc.