Clinical trials: Safety and Performance
Open Angle Glaucoma (OAG)
Safety and Performance Study of the CyPass System Applier Model 241
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used…
- Trial name
- RePASS (NCT02228577)
- Where
- Germany
- Volunteers
- 172 people
- Sponsor
- Transcend Medical, Inc.
Faecal Incontinence, Faecal Incontinence With Faecal Urgency
UCon Treatment of the Symptoms of Faecal Incontinence (FI)
UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g.…
- Trial name
- NCT05864807
- Testing
- UCon
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- InnoCon Medical
Glaucoma, Glaucoma, Open-Angle
AqueSys Microfistula Implant in Refractory Glaucoma
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
- Trial name
- NCT01640756
- Testing
- AqueSys Microfistula Implant
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- AqueSys, Inc.
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational…
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis
- Trial name
- TRESTI (NCT04943328)
- Testing
- Total Hip Arthroplasty
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Aesculap AG
Vertebral Compression Fracture
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.
- Trial name
- NCT03580434
- Testing
- V-STRUT
- Where
- 3 sites in France
- Volunteers
- 9 people
- Sponsor
- Hyprevention
Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system…
- Trial name
- NCT05536167
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Arthesys
Surgical Operation, Edentulous Jaw
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.
- Conditions
- Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
- Trial name
- Prospective_X3 (NCT05768295)
- Testing
- Axiom BL X3
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- Anthogyr
Bladder Cancer
Clinical Investigation of the Multi4 System
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
- Trial name
- NCT06136312
- Testing
- Multi4
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Multi4 Medical Ab
Peripheral Artery Disease
PMCF Study for Peripheral Arteries Below the Knee (BTK)
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC)…
- Trial name
- NCT05444660
- Where
- 5 sites in Austria, Germany
- Volunteers
- 102 people
- Sponsor
- Cordis US Corp.
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Total Knee Arthroplasty
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
- Trial name
- NCT03292003
- Testing
- Journey II BCS Total Knee System
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 1,694 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Intracranial Aneurysm
Coil Assisted Flow Diversion Safety and Performance Study
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
- Trial name
- CAFI (NCT04187573)
- Testing
- Neqstent
- Where
- 7 sites in Austria, Canada and 3 more
- Volunteers
- 38 people
- Sponsor
- Cerus Endovascular, Inc.
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging.
- Conditions
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity, Skin Turgor
- Trial name
- NCT07151859
- Testing
- PN30 (RDM16)
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mastelli S.r.l
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Vaginal Atrophy, Vulvovaginal Signs and Symptoms
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal…
- Conditions
- Vaginal Atrophy, Vulvovaginal Signs and Symptoms, Dyspareunia, Urinary Incontinence
- Trial name
- NCT04659668
- Testing
- MMG-23-04-2019
- Where
- Bulgaria
- Volunteers
- 37 people
- Sponsor
- Mesoestetic Pharma Group S.L.
Substance Use Disorder (SUD)
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances.
- Trial name
- NCT06629740
- Testing
- Measurements with a eHealth system
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
Gastroesophageal Reflux Disease (GERD)
Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which stomach acid flows back into the esophagus, causing irritation and inflammation.
- Trial name
- ARMOR (NCT06984484)
- Testing
- Afluxin®
- Where
- 7 sites in Italy
- Volunteers
- 208 people
- Sponsor
- Devintec Sagl
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular
Hip Disease, Hip Fractures
MDR - M/L Taper With Kinectiv Technology Stems and Necks
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip…
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis
- Trial name
- NCT04027140
- Testing
- M/L Taper with Kinectiv Technology Stems and Necks
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Zimmer Biomet
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