Clinical trials: Safety and Performance
Degenerative Mitral Valve Disease
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of symptomatic moderate-to-severe(3+) or severe(4+) degenerative mitral regurgitation (DMR) in high surgical risk…
- Trial name
- NCT04734756
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Lip Augmentation
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
This study will assess the safety and effectiveness of a dermal filler called DKL crosslinked hyaluronic acid 20 mg/mL with lidocaine 0.3% when injected into the lips of healthy men and women who want to have fuller lips.
- Trial name
- NCT07204691
- Testing
- DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler
- Where
- 2 sites in Sweden
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Dr. Korman Laboratories Ltd.
Hypertension, Resistant to Conventional Therapy
Continued Safety and Performance of the TIVUS System
The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts: TIVUS™ Severe Resistant HTN Cohort TIVUS™…
- Trial name
- NCT01835535
- Testing
- TIVUS
- Where
- Australia
- Volunteers
- 80 people
- Sponsor
- Cardiosonic
Labia Majora Atrophy and Hypotrophy
Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMI-22-04-2019" on the female genital area for the aesthetic…
- Trial name
- NCT04652817
- Testing
- MMI-22-04-2019
- Where
- Bulgaria
- Volunteers
- 35 people
- Sponsor
- Mesoestetic Pharma Group S.L.
Thoracic Aortic Diseases
The Single Branch NEXUS™ Clinical Study
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
- Trial name
- NexusSB (NCT03208504)
- Testing
- Nexus™ Aortic Arch Stent graft
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Endospan Ltd.
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.
Cancer, Tumor, Solid
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the…
- Conditions
- Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone
- Trial name
- BIOGUIDE-X (NCT04788147)
- Testing
- RMRS IDE Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- RefleXion Medical
Partial-thickness Burn
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial…
- Trial name
- NCT04839523
- Testing
- Exufiber, Exufiber Ag+
- Where
- 6 sites in United States
- Volunteers
- 44 people
- Sponsor
- Molnlycke Health Care AB
Pulmonary Artery Stenosis
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
- Trial name
- NCT03287024
- Testing
- BeGrow Stent System
- Where
- 3 sites in Austria, Serbia and 1 more
- Volunteers
- 18 people
- Sponsor
- Bentley InnoMed GmbH
Peripheral Arterial Disease, Peripheral Artery Disease
FRAME, External Support for Lower Limb Autologous Grafts
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment…
- Trial name
- NCT04003480
- Testing
- FRAME
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.
Diaper Rash
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life.
- Trial name
- NCT03640897
- Testing
- Liniderm, Wipes, Water
- Where
- Poland
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Laboratoires Gilbert
Atherosclerosis, Arteriosclerosis
BIOLUX P-I First in Man Study
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs.
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- NCT01221610
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 60 people
- Sponsor
- Biotronik AG
Acute Ischemic Stroke
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study
A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
- Trial name
- NCT04514562
- Testing
- NeVa Stent Retrievers
- Where
- 7 sites in United States
- Volunteers
- 120 people
- Sponsor
- Vesalio
Heart Failure
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
- Trial name
- VECTOR-HF (NCT03775161)
- Testing
- V-LAP™ System
- Where
- 2 sites in Germany, Italy
- Volunteers
- 45 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Coronary Artery Diseases
BIOFLOW III Satellite-Italy Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
- Trial name
- NCT02028728
- Where
- 18 sites in Italy
- Volunteers
- 609 people
- Sponsor
- Biotronik Italia S.p.A.
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
Knee Pain Chronic, Osteoarthritis, Knee
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
- Conditions
- Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT05787821
- Testing
- Total Knee Arthroplasty
- Where
- 16 sites in United States
- Volunteers
- 760 people
- Sponsor
- Zimmer Biomet
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.
Xerostomia
Evaluation of an Electro-stimulator for the Treatment of Xerostomia
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year.
- Trial name
- GenNarino (NCT00509808)
- Testing
- Electrostimulation
- Where
- Finland
- Volunteers
- 200 people
- Sponsor
- Saliwell Ltd.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Modulus in XLIF Study
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04418817
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- NuVasive
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