Clinical trials: Safety and Performance
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03726554
- Testing
- Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Zimmer Biomet
Heart Failure
C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily…
- Trial name
- NCT01176370
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Nuwellis, Inc.
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
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.
Respiratory Insufficiency in Children
Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.
- Trial name
- PaVoG (NCT05229172)
- Testing
- Volume Targeted Ventilation
- Where
- 5 sites in Netherlands, Poland and 1 more
- Volunteers
- 76 people
- Sponsor
- Vyaire Medical
Early Detection of Cancer, Cancer
PATHFINDER 2: A Multi-Cancer Early Detection Study
This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America.
- Trial name
- NCT05155605
- Testing
- Multi-Cancer Early Detection Test
- Where
- 56 sites in United States, Canada
- Volunteers
- 35,883 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Hernia
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
- Trial name
- NCT06042205
- Testing
- TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Where
- 5 sites in Belgium, Spain
- Volunteers
- 78 people
- Sponsor
- Tissium
Bleeding, Bypass Complication
A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Trial name
- NCT05542277
- Testing
- ClearPlasma
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 130 people
- Sponsor
- PlasFree Ltd.
Prostate Cancer
Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment.
- Trial name
- NCT07115277
- Testing
- Flotufolastat F-18 Injection
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Sinotau Pharmaceutical Group
Chronic Total Occlusion
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total…
- Trial name
- NCT02358629
- Testing
- NovaCross™ microcatheter
- Where
- Poland
- Volunteers
- 14 people
- Sponsor
- Nitiloop Ltd.
Paroxysmal Atrial Fibrillation
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial…
- Trial name
- NCT05114954
- Testing
- CardioPulsesTM pulsed field ablation system
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Common Warts, Plantar Warts
Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
Common and plantar warts are a type of skin lesion caused by infection with the human papilloma virus. The incidence of warts is relatively high, with an estimated few to several per cent of the adult population affected.
- Trial name
- NCT06958237
- Testing
- salicylic acid wart patches
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Langsteiner sp. z o.o.
Coronary Artery Disease
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting
- Trial name
- BIOSOLVE-IV (NCT02817802)
- Testing
- Magmaris
- Where
- 2 sites in Belgium, Hong Kong
- Volunteers
- 2,066 people
- Sponsor
- Biotronik AG
Wrinkles
Injectable Filler for Facial Soft Tissue Augmentation
The purpose of this study is to assess the safety and performance of Hydroxytite in all subjects who have received sub dermal or deep dermal injections.
- Trial name
- NCT02218788
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Panaxia Ltd
Prostate Cancer, Kidney Cancer
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
- Conditions
- Prostate Cancer, Kidney Cancer, Congenital Abnormality of Kidney, Nephrolithiasis
- Trial name
- DOSTILCU (NCT04869462)
- Where
- Germany
- Volunteers
- 67 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease, Chronic Low-back Pain
Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
- Trial name
- PMCF1 (NCT05105490)
- Testing
- PerQdisc
- Where
- Germany
- Sponsor
- Spinal Stabilization Technologies
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
- Trial name
- NOBLE-Laparo (NCT03873181)
- Testing
- HEMOBLAST™ Bellows
- Where
- 8 sites in Austria, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Biom'Up France SAS
Intraventricular Hemorrhage, Subarachnoid Hemorrhage
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)
The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).
- Trial name
- NCT05113381
- Testing
- CerebroFlo™ EVD Catheter
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Integra LifeSciences Corporation
Peripheral Arterial Disease
Remedy, Biodegradable Peripheral Stent Registry
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries.
- Trial name
- NCT01420120
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- be Medical
Cerumen Impaction of Both Ears
Earol Madrid Study
Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear wax not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may…
- Trial name
- EMS (NCT04653662)
- Testing
- Earol
- Where
- 5 sites in Spain
- Volunteers
- 108 people
- Sponsor
- HL Healthcare Ltd
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