Clinical trials: Performance
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Brain Arteriovenous Malformations
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%
- Trial name
- NCT00857662
- Testing
- Onyx, TRUFILL
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Hearing Loss, Bilateral, Hearing Loss, Unilateral
PRINCE22 System Complete Performance Study
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise.
- Trial name
- NCT05656313
- Testing
- Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Sonova AG
Anastomosis, Surgical
Evaluation of MUSA-3 in Microsurgical Anastomoses
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
- Trial name
- NCT07427823
- Testing
- Robot-assisted microsurgical anastomoses
- Volunteers
- 30 people
- Sponsor
- Microsure
Caries Pit and Fissure Limited to Enamel
Clinical Performance of Two Fissure Sealants
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
- Trial name
- NCT03470129
- Testing
- fissure sealing
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Ivoclar Vivadent AG
Pulmonary Disease, Chronic Obstructive
Ventilator Adapters for Combivent Respimat
The general aim of this 1-day, open label, non-randomised, trial is to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler with patients requiring mechanical ventilation.
- Trial name
- NCT01969539
- Testing
- Combivent Respimat via tee adapter, Combivent Respimat via ventilator adapter
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Boehringer Ingelheim
Dental Prosthesis, Implant-Supported
A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.
This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to…
- Trial name
- NCT06600451
- Testing
- observational study, no intervention is required
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Nobel Biocare
End Stage Renal Disease
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
- Trial name
- NCT00131872
- Testing
- Expedial Vascular Access Graft
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LeMaitre Vascular
Blood Pressure
Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the…
- Trial name
- NCT04027777
- Testing
- Aktiia.product-P0
- Where
- Switzerland
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Autoimmune Diseases
Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased…
- Trial name
- plasmaFlux (NCT06382675)
- Testing
- Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
- Where
- 7 sites in Germany
- Volunteers
- 46 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Herpes Labialis
Study of a Cold Sore Patch for the Treatment of Herpes Labialis
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore…
- Trial name
- NCT01484067
- Testing
- Patch ( Compeed© Total CareTM Cold Sore Patch)
- Where
- United Kingdom
- Volunteers
- 472 people
- Sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Trauma
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared…
- Trial name
- NCT02408029
- Testing
- Observational study - no intervention
- Where
- 3 sites in United States
- Volunteers
- 325 people
- Sponsor
- Coramed Technologies LLC
Transforaminal Lumbar Interbody Fusion Surgery
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
- Trial name
- EARP-2 (NCT07020000)
- Testing
- Device: Nerve Cuff and Retractor System
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- Retropsoas Technologies, LLC
Degenerative Mitral Valve Disease
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
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 (DMR) in high surgical risk…
- Trial name
- NCT04734756
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Vascular Disease, Dissection
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with…
- Conditions
- Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta
- Trial name
- TGR 23-02TA (NCT06658730)
- Testing
- Endovascular
- Where
- 37 sites in United States, Denmark and 8 more
- Volunteers
- 1,500 people
- Sponsor
- W.L.Gore & Associates
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.
Heart Rate Variability, Exercise
Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance
Heart rate variability (HRV) is a measure of the variation in time between each heartbeat. It is an indirect and ubiquitous biomarker of performance readiness and recovery measured by most consumer-grade wearable fitness…
- Trial name
- NCT06425939
- Testing
- Force plate assessment, Whoop wrist band
- Where
- 2 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Healthy Volunteers
SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
- Trial name
- NCT05476107
- Testing
- AMT-126, Radioactive Tablet (Part 2 Only)
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Applied Molecular Transport