Clinical trials: Safety and Performance
Obstructive Sleep Apnea
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Trial name
- NCT02312479
- Testing
- Nyxoah SAT system
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- Nyxoah S.A.
Obstructed Biliary and Pancreatic Duct
To Evaluate the Safety and Clinical Performance of the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium.
- Trial name
- Registry (NCT04708288)
- Testing
- ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
- Where
- 11 sites in Finland, France and 6 more
- Volunteers
- 198 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Ischemic Heart Disease
BIOFLOW-SV Portugal Registry
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm
- Trial name
- BIOFLOW-SV (NCT03600961)
- Testing
- Orsiro Sirolimus Eluting Coronary Stent System
- Where
- 4 sites in Portugal
- Volunteers
- 173 people
- Sponsor
- Biotronik AG
Lips Enhancement, Nasolabial Fold Correction
Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler
Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be…
- Conditions
- Lips Enhancement, Nasolabial Fold Correction, Midface Volume Deficit
- Trial name
- NCT04971876
- Testing
- HLR-1, HLR-2, HLR-3
- Where
- 3 sites in Germany, Poland
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Hallura Ltd.
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Bone Metastases
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone metastases of malignant tumors compared with…
- Trial name
- NCT05614518
- Testing
- Sodium Fluoride F-18 Injection, Technetium[99mTc] Methylenediphosphonate Injection
- Where
- China
- Volunteers
- 280 people
- Sponsor
- HTA Co., Ltd.
Leg Ulcer
EASH Dressing on Chronic Venous Leg Ulcers
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
- Trial name
- NCT01497210
- Testing
- EASH dressing
- Where
- 6 sites in Poland, United Kingdom
- Volunteers
- 40 people
- Sponsor
- ConvaTec Inc.
Acute Ischemic Stroke
A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter
This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.
- Trial name
- NCT05119647
- Testing
- Thrombus Aspiration Catheter(Ton-bridgeMT)
- Where
- 15 sites in China
- Volunteers
- 124 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Cataract, AMD - Age-Related Macular Degeneration
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
The goal of this clinical trial is to evaluate the safety, visual performance, and potential clinical benefits of the LENTIS® MAX LS-313 MF80 intraocular lens compared with the monofocal LENTIS® L-313 intraocular lens in adult…
- Trial name
- NCT07915076
- Testing
- Intraocular Lens
- Volunteers
- 35 people
- Sponsor
- Teleon Surgical B.V.
Proctological Disorders
A New Class IIb MD in Proctological Disorders
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids…
- Trial name
- NCT03833076
- Testing
- Medical device Procto
- Where
- Italy
- Volunteers
- 118 people
- Sponsor
- Nathura S.p.A
Mild Defects of the Lips
Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
- Trial name
- NCT07831213
- Where
- Israel
- Volunteers
- 87 people
- Sponsor
- Glyance
Dental Implants
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments.
- Trial name
- NCT06960460
- Testing
- Dental implant surgery with ZygoFixU implants
- Where
- 3 sites in France, Italy
- Volunteers
- 99 people
- Sponsor
- Global D
Wrinkles
Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume
This study designed to evaluate the safety and performance of RefillHA Volume, a dermal filler for facial soft tissue augmentation and correction of facial wrinkles and folds in routine clinical setting.
- Trial name
- NCT07329608
- Where
- Israel
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Glyance
Carotid Artery Diseases, Aortic Diseases
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement…
- Conditions
- Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases
- Trial name
- NCT07322913
- Testing
- Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
- Where
- 5 sites in United States, Belgium and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Intervascular
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
Herpes Labialis
Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis
The primary objective of this study was to evaluate the safety and performance of a cold sore patch for the treatment of herpes labialis.
- Trial name
- NCT01208298
- Testing
- Cold Sore Patch
- Where
- 2 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
ACL Repair, Posterior Cruciate Ligament (PCL) Repair
BIOSURE™ RG Knee Safety & Performance Study
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
- Conditions
- ACL Repair, Posterior Cruciate Ligament (PCL) Repair, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL)
- Trial name
- NCT03519555
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Smith & Nephew, Inc.
Wound
PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
- Trial name
- NCT05690685
- Testing
- Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
- Where
- 2 sites in United Kingdom
- Volunteers
- 56 people
- Sponsor
- Advanced Medical Solutions Ltd.
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
Transcatheter Aortic Valve Replacement
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high…
- Trial name
- NCT01627691
- Testing
- Lotus Valve System
- Where
- 20 sites in Australia, France and 7 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
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