Clinical trials: Safety and Performance
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Elevated Intraocular Pressure (IOP)
Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer
The device being studied in this research is the investigational PIB, a tool designed to measure eye pressure without touching the eye.
- Trial name
- PIB (NCT07762053)
- Testing
- Photobionic IOP Tonometer (PIB)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- EyeCBetter Corporation
Hyperglycemia
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
- Trial name
- MAHI (NCT01763567)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Medtronic MiniMed, Inc.
Dry Eye Syndrome (DES)
Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%
This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation aim to evaluate the efficacy and tollerability of two types of eye drops containing Hyaluronic acid (HA) with different…
- Trial name
- NCT06189456
- Testing
- BLUgel A, BLUyal A
- Where
- 3 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Ileostomy - Stoma
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Trial name
- NCT01957553
- Testing
- Coloplast test product, SenSura
- Where
- 17 sites in Belgium, Denmark and 3 more
- Volunteers
- 130 people
- Sponsor
- Coloplast A/S
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
Coronary Artery Disease
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.
- Trial name
- NCT01426139
- Testing
- Percutaneous Coronary Intervention Biotronik Orsiro DES
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Biotronik AG
Safety and Performance of the Nellix Endovascular Sealing System
Nellix® Registry Study: EVAS-Global
This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site.
- Trial name
- EVAS-FORWARD 1 (NCT02018744)
- Where
- 19 sites in Germany, Latvia and 6 more
- Volunteers
- 300 people
- Sponsor
- Endologix
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
ACL Rupture
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive…
- Trial name
- DT4-EBMCA (NCT06990100)
- Testing
- ACL surgery
- Where
- France
- Volunteers
- 36 people
- Sponsor
- SACIMEX
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Safety and Performance of Dressing Adhesive on Healthy Volunteers
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border.
- Trial name
- NCT01897285
- Testing
- AQUACEL® foam adhesive dressing
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ConvaTec Inc.
Vaginal Atrophy
Real-world Evidence Study on the Performance and Safety of Halova Ovules
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy…
- Trial name
- NCT05654610
- Testing
- Halova
- Where
- 14 sites in Romania
- Volunteers
- 249 people
- Sponsor
- Perfect Care Distribution
Heart Failure; With Decompensation, Cardiorenal Syndrome
The Aortix CRS Pilot Study
The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure
- Trial name
- NCT04145635
- Testing
- Aortix System
- Where
- 19 sites in United States, Australia
- Volunteers
- 21 people
- Sponsor
- Procyrion
Aging, Premature
Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance
This is a pivotal, prospective active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL crosslinked sodium hyaluronate 23 versus Juvederm…
- Trial name
- NCT05021913
- Testing
- DKL crosslinked sodium hyaluronate 23, Juvéderm Volift™ with lidocaine (Allergan, Inc)
- Where
- Sweden
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Korman Laboratories Ltd.
Breast Tissue Accessory, Breast Cancer
Motiva Flora Tissue Expander PMCF
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of…
- Trial name
- NCT05447988
- Testing
- Breast Tissue Expander
- Where
- 5 sites in Chile, Costa Rica and 2 more
- Volunteers
- 136 people
- Sponsor
- Establishment Labs
Clostridium Difficile Infection
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the…
- Trial name
- SHIELD (NCT03710694)
- Testing
- DAV132
- Where
- 29 sites in Bulgaria, Germany and 2 more
- Volunteers
- 260 people
- Sponsor
- Da Volterra
Obesity
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
- Trial name
- NCT01422941
- Testing
- CAVU Attune Device
- Where
- 2 sites in Australia
- Volunteers
- 40 people
- Sponsor
- Cavu Medical, Inc.
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