Clinical trials: Medical Device Performance
Large Hole Percutaneous Venous Closure
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F)…
- Trial name
- ELITE-Venous (NCT06007339)
- Testing
- PerQseal ELITE
- Where
- Netherlands
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Obstetric Anal Sphincter Injury, Delivery Complication
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04903977
- Testing
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound
- Where
- 5 sites in Czechia, Poland and 2 more
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- OASIS Diagnostics S.A.
Diabetes
Performance Evaluation of Lucie™ for Hydration of Dialysis Patients
The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure.
- Trial name
- PERF-LUCIE (NCT06640270)
- Testing
- Diabetes Treatment
- Volunteers
- 150 people
- Sponsor
- Home Habilis
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Osteo Arthritis Knee, Knee Arthritis
Persona IQ Cohort Study
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative…
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty
- Trial name
- NCT06089291
- Testing
- Persona IQ
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Vaginal Disease
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
The objective of the present PMCF study with a 6 month follow up period is to identify potential new and unknown risks associated with longer term use of Ainara® and (considering the duration of symptoms in GSM) to collect…
- Trial name
- NCT04362371
- Testing
- Ainara
- Where
- Romania
- Volunteers
- 73 people
- Sponsor
- Italfarmaco
Abnormalities, Jaw, Malocclusion, Angle Class III
First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric…
- Trial name
- NCT03901209
- Testing
- Mid-face osteotomy
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 31 people
- Sponsor
- Advanced Osteotomy Tools (AOT) AG
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma 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/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
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
Excess Abdominal Fat
UltraShape Power Device for Fat Reduction in Flanks
Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.
- Trial name
- NCT03502473
- Testing
- UltraShape Power device
- Where
- Israel
- Volunteers
- healthy volunteers welcome
- Sponsor
- Syneron Medical
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Pregnancy Related
Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use…
- Trial name
- PRESTO (NCT05765539)
- Testing
- echOpen O1 Handheld Ultrasound device
- Where
- 2 sites in Senegal
- Volunteers
- 224 people
- Sponsor
- echOpen Factory
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Healthy Subjects
A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device
This clinical study will be performed in three phases. The purpose of Phase 1 of this study is to compare the ECG data recorded using the ZywieZ3 Sensor and ZywieZ3 Adhesive ("Test Device") to the data recorded by a traditional…
- Trial name
- NCT07200232
- Testing
- Phase 1 Test Device Sensor and Adhesive and Reference Device, Phase 2 Test Device ECG Signal quality over a 10-day simulated use period, Test Device Sensor and Adhesive Variable Placement
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Zywie, Inc.
Facial Wrinkles, Skin Aging
Evaluation of MD60002 Device for Facial Skin Aging
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic…
- Conditions
- Facial Wrinkles, Skin Aging, Skin Imperfections
- Trial name
- CIP-02-25 (NCT07881926)
- Testing
- Device: MD60002
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Promoitalia Group Spa
Scar
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the…
- Trial name
- PMCS EURO HEAL (NCT01706848)
- Testing
- Celotres, Surgical Closure by Standard of Care
- Where
- 9 sites in Poland, United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Halscion, Inc.
Proctological Disorders
A New Class IIb MD in Proctological Disorders
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids…
- Trial name
- NCT03833076
- Testing
- Medical device Procto
- Where
- Italy
- Volunteers
- 118 people
- Sponsor
- Nathura S.p.A