Clinical trials: Performance
Intra Abdominal Pressure, Intra-Abdominal Hypertension
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP).
- Trial name
- NCT07400666
- Testing
- digital capsule
- Volunteers
- 26 people
- Sponsor
- Dotspace Inc.
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Liver Transplantation
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
- Trial name
- PILOT™_CA (NCT05574361)
- Testing
- Hypothermic Machine Perfusion
- Where
- 5 sites in United States
- Volunteers
- 385 people
- Sponsor
- Organ Recovery Systems, Inc.
Trapeziometacarpal Osteoarthritis, Rhizarthrosis
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix.
- Conditions
- Trapeziometacarpal Osteoarthritis, Rhizarthrosis, MEDICAL DEVICE, Infiltrate
- Trial name
- SMAGENART (NCT06781554)
- Testing
- MD-Small Joints Collagen Medical Device
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Guna S.p.a
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Neuro 1 vs. Neuro 2 Sound Processors
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and…
- Trial name
- NCT03756337
- Testing
- Neuro 1 & Neuro 2, Neuro 2 & Neuro 1
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Oticon Medical
Visual Performance
Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3- treatment crossover study. The objective of this study is to evaluate the effect of JJVC senofilcon A - based contact lens with new…
- Trial name
- NCT03330275
- Testing
- Investigational Contact Lens, Commercial ACUVUE OASYS, Commercial ACUVUE OASYS and Spectacles
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Mitral Valve Insufficiency
DragonFly EU Pivotal Study
To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk…
- Trial name
- NCT05927441
- Testing
- DragonFly Transcatheter Mitral Valve Repair System
- Where
- Germany
- Volunteers
- 168 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Asthma
Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or…
- Trial name
- NCT02417961
- Testing
- Benralizumab
- Where
- 23 sites in United States, Canada
- Volunteers
- 162 people
- Sponsor
- AstraZeneca
Breast Feeding
Assessment of Annabella Breast Pump Performance
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.
- Trial name
- NCT04363073
- Testing
- Annabella Breast Pump, Control Breast Pump
- Where
- Israel
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Annabella Tech Ltd
Ventricular Arrythmia, Lead
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE…
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- FRIENDS (NCT03766919)
- Testing
- Implant of the INVICTA lead
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
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
Spinal Muscular Atrophy, Spine Deformity
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Trial name
- PIERRE (NCT05866419)
- Testing
- ThecaFlex DRx System
- Where
- 21 sites in United States, Germany and 3 more
- Volunteers
- 90 people
- Sponsor
- Alcyone Therapeutics, Inc
Bacterial Vaginosis
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.
- Trial name
- NCT07241871
- Testing
- Lactal Gel (Class IIa medical device)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Rolf Kullgren AB
Myopia
A Study to Evaluate a Modified Contact Lens
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently…
- Trial name
- NCT01391364
- Testing
- SofLens in investigational solution, SofLens in currently marketed solution
- Where
- United States
- Volunteers
- 438 people
- Sponsor
- Bausch & Lomb Incorporated
Vulvovaginal Candidiasis
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
- Trial name
- EpHect (NCT05507333)
- Testing
- pHyph generation II
- Where
- 4 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- Gedea Biotech AB
Pelvic Organ Prolapse
Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement
The purpose of this study is to clinically assess the safety and performance of the EndoFast Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.
- Trial name
- NCT00446693
- Testing
- EndoFast Reliant™ system for Pelvic Organ Prolapse repair
- Where
- 3 sites in France, Israel
- Volunteers
- 20 people
- Sponsor
- Endogun Medical Systems Ltd.
Myopia
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
- Trial name
- NCT01309867
- Testing
- Investigational Toric Lens, PureVision Toric Lens
- Where
- United States
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Ventricular Arrythmia, Lead
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- APOLLO (NCT04590144)
- Testing
- INVICTA lead
- Where
- 45 sites in Austria, France and 6 more
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Hyperopia, Myopia
Clinical Study of Visibility Tinted Clariti Contact Lens
The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone…
- Trial name
- NCT01996787
- Testing
- Air Optix Aqua, Clariti with Handling Tint
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sauflon Pharmaceuticals Ltd