Clinical trials: Safety and Performance
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting…
- Trial name
- ENHANCE II (NCT07286201)
- Testing
- OCEAN, Steroid-eluting sinus stent
- Where
- 9 sites in United States
- Volunteers
- 110 people
- Sponsor
- Polyganics BV
Cataract, Lens Opacities
Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs…
- Trial name
- NCT06105190
- Testing
- Implantation of premium monofocal IOL, LuxSmart (device under investigation), Implantation of monofocal IOL, LuxGood (control device)
- Where
- 8 sites in Austria, Czechia and 4 more
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Cutting Edge SAS
Colostomy
One Piece Closed Pouch in Subjects With a Colostomy
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
- Trial name
- NCT01935999
- Testing
- One piece closed pouch
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- ConvaTec Inc.
Verruca, Plantar Wart
Safety & Performance Study of Verruca Treatment Device
This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult…
- Trial name
- NCT01536834
- Testing
- Medical Device
- Where
- United Kingdom
- Volunteers
- 35 people
- Sponsor
- Reckitt Benckiser LLC
Respiratory Insufficiency Syndrome of Newborn
A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with…
- Trial name
- NCT05823909
- Testing
- fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation), fabian Therapy evolution ventilators with manual FiO2 control
- Where
- 2 sites in Italy
- Volunteers
- 47 people
- Sponsor
- Vyaire Medical
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Canada Satellite Registry
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success.
- Trial name
- NCT01880242
- Where
- 2 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Biotronik Canada Inc
Tooth Extraction Site Healing, Ridge Augmentation
Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations
This study's objective is to evaluate OsteoAdapt DE's safety and performance in comparison to Xenograft particulate bone graft for alveolar ridge augmentation.
- Conditions
- Tooth Extraction Site Healing, Ridge Augmentation, Bone Graft
- Trial name
- RESTORE (NCT07078331)
- Testing
- OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg), Xenograft Bone Graft
- Where
- 6 sites in Armenia, Israel
- Volunteers
- 45 people
- Sponsor
- Theradaptive, Inc
Sarcopenia, Gait Disorders in Old Age
A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test.
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Trial name
- SARA-INT (NCT03452488)
- Testing
- BIO101
- Where
- 22 sites in United States, Belgium
- Volunteers
- 233 people
- Sponsor
- Biophytis
Knee Ligament Injury
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications.
- Trial name
- NCT04076956
- Testing
- Anterior Cruciate Ligament Reconstruction
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Biomatlante
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine…
- Trial name
- NCT07764679
- Testing
- [18F]Fluorbetazine injection
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HTA Co., Ltd.
Bradycardia
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen…
- Trial name
- XTR (NCT06115980)
- Testing
- lead extraction (Xtrac O.S. system)
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Xtrac O.S.
Catheterization, Peripheral
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
The main objectives of the study are: To evaluate the performance and safety of the CiTop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology.
- Trial name
- NCT00482742
- Testing
- CiTop(TM) Guidewire
- Where
- 3 sites in Croatia, Israel
- Volunteers
- 50 people
- Sponsor
- Ovalum
Ischemic Stroke
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
Prospective, single-arm, open label, Safety and Performance clinical investigation.
- Trial name
- NCT02994563
- Testing
- Thrombectomy Device
- Where
- 4 sites in Spain, Sweden
- Volunteers
- 5 people
- Sponsor
- Amnis Therapeutics
Low Back Pain
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain.
- Trial name
- EXODOMICILE (NCT07195422)
- Testing
- Japet.W+, Control (Standard treatment)
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Japet Medical Devices
PreDiabetes, Pre Diabetes
STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
The primary objective of STAR01 is to evaluate the performance and safety of the medical device (class IIb) SiPore15™ after a 12-week long treatment in the target population of obese and overweight subjects with prediabetes or…
- Conditions
- PreDiabetes, Pre Diabetes, Prediabetic State, Type2 Diabetes
- Trial name
- NCT03823027
- Testing
- SiPore15™
- Where
- 2 sites in Finland, Sweden
- Volunteers
- 43 people
- Sponsor
- Sigrid Therapeutics AB
Diabetes (Insulin-requiring, Type 1 or Type 2)
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the…
- Trial name
- NEXUS (NCT07227805)
- Testing
- NMX8, 780G
- Where
- 9 sites in Belgium, Denmark and 2 more
- Volunteers
- 116 people
- Sponsor
- Medtronic MiniMed, Inc.
Benign Prostatic Hyperplasia
The Zenflow Spring System Safety, Performance and Effectiveness Study
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
- Trial name
- ZEST2 (NCT03595735)
- Testing
- Zenflow Spring System
- Where
- 3 sites in Mexico
- Volunteers
- 40 people
- Sponsor
- Zenflow, Inc.
Chronic Pain
Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a…
- Trial name
- Domburg (NCT04627974)
- Testing
- Evoke Spinal Cord Stimulation (SCS) System
- Where
- 8 sites in Belgium, Germany and 2 more
- Volunteers
- 70 people
- Sponsor
- Saluda Medical Pty Ltd
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
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