Clinical trials: Safety and Performance
Atrophy Vulva
POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.
The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning…
- Trial name
- NCT06797167
- Testing
- Injections of a filler gel containing cross-linked hyaluronic acid
- Where
- Italy
- Volunteers
- 76 people
- Sponsor
- Rose Pharma SA
Tibia Fracture
OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting
A prospective, randomized, evaluator-blinded, controlled study for subjects with open tibial fractures classified as Gustilo type II, IIIA or IIIB (see Appendix 1) who will receive bone graft implantation for the potential of…
- Trial name
- NCT04960722
- Testing
- OIF/β-TCP
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- BioGend Therapeutics Co.Ltd
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
Roux-en-Y Gastric Bypass, Obesity
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses.
- Trial name
- NCT03968757
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
Cerebrospinal Fluid Leak
Suturable DuraGen™ PMCF Study
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
- Trial name
- NCT04923867
- Testing
- Suturable DuraGen™
- Where
- 3 sites in United States
- Volunteers
- 106 people
- Sponsor
- Integra LifeSciences Corporation
Cochlear Implants
Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey
Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user…
- Trial name
- NCT06817928
- Where
- Austria
- Volunteers
- 46 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Colorectal Anastomosis, Left-sided Colon Resection
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in…
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication
- Trial name
- SECURE (NCT07351071)
- Testing
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Where
- 10 sites in United States
- Volunteers
- 137 people
- Sponsor
- Medtronic - MITG
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Suture-Mediated Large Bore Closure Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- FASTEN (NCT06851481)
- Testing
- Ladera LBC System
- Where
- 6 sites in Australia, Belgium and 1 more
- Volunteers
- 55 people
- Sponsor
- Ladera Medical
Ichthyosis
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis
28 Day Survey study in patients with Ichthyosis
- Trial name
- NCT07783165
- Testing
- Doublebase Once
- Volunteers
- 100 people
- Sponsor
- Dermal Laboratories Ltd
Herniated Disk Lumbar
Evaluation of Plenum® Tissue Ortho to Prevent Epidural Fibrosis and Post-laminectomy Syndrome.
The goal of this clinical trial is to compare if adding a polydioxanone membrane prevents epidural fibrosis and, consequently, the rate of occurrence of the post-laminectomy syndrome in participants undergoing microdiscectomy for…
- Trial name
- NCT05776628
- Testing
- Plenum® Tissue ortho membrane (polydioxanone membrane)
- Where
- Brazil
- Volunteers
- 36 people
- Sponsor
- M3 Health
Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
This is a profit, multicentric, prospective, single-arm, open-label, non-pharmacological clinical investigation. Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive…
- Trial name
- NCT06190054
- Testing
- MERAMIRT
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Osteoarthritis, Rheumatoid Arthritis
Exceed ABT Acetabular Cup Cementless System
A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
- Trial name
- NCT04255394
- Volunteers
- 677 people
- Sponsor
- Zimmer Biomet
Attention Deficit Hyperactivity Disorder
A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators
The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
- Trial name
- NCT00458445
- Testing
- SPD465
- Where
- United States
- Sponsor
- Shire
Refractive Ametropia
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
13 weeks, open-label, daily disposable contact lens dispensing study.
- Trial name
- NCT07322211
- Testing
- Treatment
- Where
- 2 sites in Taiwan
- Volunteers
- 35 people
- Sponsor
- Unicon Optical Co. Ltd.
End-stage Renal Disease
Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other…
- Trial name
- NCT04395131
- Testing
- Clearum HF Hemodialyzer
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Mozarc Medical US LLC
C.Surgical Procedure; Vascular (Peripheral)
Seal-V Safety and Performance Study
The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using…
- Trial name
- NCT01625481
- Testing
- Seal-V
- Where
- 3 sites in Israel
- Volunteers
- 23 people
- Sponsor
- Sealantis Ltd.
Clear Cell Renal Cell Carcinoma
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON…
- Trial name
- NCT06750419
- Testing
- 89Zr-TLX250 PET/CT
- Where
- 8 sites in China
- Volunteers
- 82 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Gastro Esophageal Reflux
Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment
This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD.
- Trial name
- NCT04202692
- Testing
- Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- SOFAR S.p.A.
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH
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