Clinical trials: Safety and Performance
Tattoo Removal
Performance Evaluation of Tattoo Removal
Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal
- Trial name
- NCT03866304
- Testing
- Device: S2 Picosecond laser
- Where
- Lithuania
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- LigthSense Israel Ltd
Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis
MDR - Longevity IT Oblique and Offset Liners
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used…
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli, Traumatic Arthritis
- Trial name
- NCT05980234
- Testing
- Total Hip Arthroplasty with Longevity IT Oblique Liners, Total Hip Arthroplasty with Longevity IT Offset Liners
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zimmer Biomet
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.
Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System…
- Conditions
- Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis, Osteoarthritis, Hip, Avascular Necrosis
- Trial name
- NCT03372278
- Where
- 8 sites in Australia, Belgium and 6 more
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet
Dry Eye Syndrome
Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36…
- Trial name
- NCT06375499
- Testing
- T2769, Hylo-Forte®
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 74 people
- Sponsor
- Laboratoires Thea
Coronary Artery Disease, Coronary Restenosis
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of…
- Conditions
- Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Trial name
- AGENT-ISR (NCT02151812)
- Testing
- Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
- Where
- 12 sites in France, Germany
- Volunteers
- 123 people
- Sponsor
- Hemoteq AG
Oncology
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®.
- Trial name
- NCT05316077
- Where
- 3 sites in Austria, France and 1 more
- Volunteers
- 50 people
- Sponsor
- Guerbet
Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray
Clinical Trial of Intranasal Delivery of NT-301
The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301…
- Conditions
- Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
- Trial name
- APPROVE (NCT06954428)
- Testing
- NT-301 1 mg, NT-301 2 mg
- Where
- 2 sites in Australia
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Nano PharmaSolutions Australia
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Diabetes Mellitus, Type 2
Safety and Performance of the Glyconics-SX System
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
- ANODE01 (NCT05198895)
- Testing
- Near-infrared (NIR)
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
Aortic Dissection Type B
Dragon Study Europe
Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It is designed to evaluate safety and performance of the MFM for the treatment of chronic type B aortic dissection.
- Trial name
- NCT03033771
- Testing
- Implantation with the Multilayer Flow Modulator (MFM)
- Where
- 4 sites in Bulgaria, Romania
- Volunteers
- 27 people
- Sponsor
- Cardiatis
Carotid Artery Stenoses
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
- Trial name
- NCT02501148
- Testing
- carotid artery stenting
- Where
- 5 sites in Germany
- Volunteers
- 106 people
- Sponsor
- Contego Medical, Inc.
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.
Atrial Fibrillation
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
- Trial name
- CAI (NCT02770989)
- Testing
- Vimecon Laser CAI percutaneous cardiac ablation
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 1 people
- Sponsor
- Vimecon GmbH
Digital Nerve Injury
NeuraGen 3D Pilot Study
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve…
- Trial name
- NCT05343143
- Testing
- NeuraGen 3D Nerve Guide Matrix
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Integra LifeSciences Corporation
Calcaneus Fracture, Calcaneus Deformity of Foot
A Clinical Study Carried Out in Patients Operated With Calcanail®
This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.
- Conditions
- Calcaneus Fracture, Calcaneus Deformity of Foot, Arthrosis; Localized
- Trial name
- NCT06234358
- Testing
- osteosynthesis
- Where
- France
- Volunteers
- 84 people
- Sponsor
- FH ORTHO
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
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.
Venous Leg Ulcer (VLU)
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers
- Trial name
- NCT07692178
- Testing
- EX-03
- Volunteers
- 20 people
- Sponsor
- MediWound Ltd
Aortic Valve Stenosis
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in…
- Trial name
- REPRISE EDGE (NCT02854319)
- Testing
- LOTUS Edge Valve System
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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