Clinical trials: Medical Devices
Facial Volume
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® XL for the Restoration and/or Augmentation of Facial Volume
The process of facial aging is a result of intricate alterations occurring at both the microscopic and macroscopic levels, leading to changes in facial volume.
- Trial name
- NCT06828198
- Testing
- KOS® XL
- Where
- Romania
- Volunteers
- 34 people
- Sponsor
- Quantum Beauty Kozmetik
Schizophrenia
A Study to Evaluate the Overall Effects of Treatment With Abbreviated CT-156 in People With Schizophrenia
An exploratory, double-arm, 4-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.
- Trial name
- NCT06136936
- Testing
- CT-156-C-001
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Click Therapeutics, Inc.
Dental Devices, Home Care
Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush
To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing.
- Trial name
- NCT06292611
- Testing
- Battery operated toothbrush, Manual toothbrush
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst
Hot AXIOS System Japan Post Market Survey
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Trial name
- NCT03797209
- Testing
- EUS-guided fistulization AXIOS
- Where
- 40 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Boston Scientific Japan K.K.
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices
The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices.
- Trial name
- NCT06003465
- Testing
- LY3437943, Test, Reference
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Prolapse; Female
Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.
An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).
- Trial name
- SCUPP (NCT06620211)
- Testing
- promontofixation, prolapse cure
- Where
- France
- Volunteers
- 290 people
- Sponsor
- Cousin Biotech
Device Safety
Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel…
- Trial name
- GEM (NCT07135011)
- Testing
- Primary gluteal enhancement
- Where
- Costa Rica
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Acute on Chronic Liver Failure
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure…
- Trial name
- DIALIVE _ACLF (NCT03065699)
- Testing
- DIALIVE Liver Dialysis Device
- Where
- 12 sites in Austria, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- Yaqrit Ltd
Patent Foramen Ovale, Stroke
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder…
- Conditions
- Patent Foramen Ovale, Stroke, Transient Ischemic Attack (TIA)
- Trial name
- SAFE-PFO (NCT07380490)
- Testing
- PFO Closure procedure
- Where
- Germany
- Volunteers
- 1,260 people
- Sponsor
- Giuseppe Tarantini
Age-related Cataract, Vision Loss
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract
- Trial name
- EB-CE-02 (NCT07246915)
- Where
- 6 sites in Romania
- Volunteers
- 47 people
- Sponsor
- Edinburgh Biosciences Ltd
Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Trial name
- NCT05253976
- Where
- Switzerland
- Sponsor
- Zimmer Biomet
Knee Surgery
FH ORTHO SAS Knee Observatory
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE)…
- Trial name
- NCT06207968
- Testing
- Knee surgery with FH Ortho devices
- Where
- 10 sites in France
- Volunteers
- 487 people
- Sponsor
- FH ORTHO
Hip Fractures
Effect of a Robotic Platform for Hip Fracture Rehab
Hip fracture is one of the most common traumas associated with falls in the elderly, severely affecting the patient's mobility and independence.
- Trial name
- NCT05079555
- Testing
- Robotic rehab
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Werium Assistive Solutions
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Cataract
Galilei Lens Professional vs. Predicate Devices: a Comparison Study
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract…
- Trial name
- NCT01961089
- Testing
- Galilei Lens Professional, IOLMaster, Lenstar
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ziemer Ophthalmic Systems AG