Clinical trials: Medical Device Performance
Cholangiopancreatography, Endoscopic Retrograde
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered…
- Trial name
- SAMISEN-B (NCT05129449)
- Testing
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 89 people
- Sponsor
- Olympus Europe SE & Co. KG
Healthy Normals
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.
- Trial name
- NCT03257189
- Testing
- Physiological signal monitor, Heart rate and heart rate variability comparison device, Respiration rate comparison device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MC10 Inc.
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Haemorrhoidal Disease
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS
This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification)…
- Trial name
- NCT06944951
- Testing
- Hydrophilic emulsion for the relief of haemorroidal symptoms
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Biokosmes Srl
Benign Gallbladder Disease
Levita Magnetic Grasper Device Safety and Performance Study
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
- Trial name
- NCT02049983
- Testing
- Use of Levita Magnetics Grasper
- Where
- 3 sites in Chile
- Volunteers
- 50 people
- Sponsor
- Levita Magnetics
Pregnancy
Maternal Fetal Device Performance Singleton
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients.
- Trial name
- NCT03085238
- Testing
- M-Trap
- Where
- 8 sites in Spain
- Volunteers
- 23 people
- Sponsor
- MTrap, Inc.
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Epicondylitis of the Elbow, Biceps Tendon Disorder
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Trial name
- NCT05519228
- Testing
- ToggleLoc 2.9 mm Soft Tissue System
- Where
- 2 sites in United States, Spain
- Volunteers
- 83 people
- Sponsor
- Zimmer Biomet
Respiratory Failure
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and…
- Trial name
- LMANURSING (NCT01659268)
- Testing
- Simulation class, Exhibition-dialogued class
- Where
- Brazil
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Body Fat
Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
- Trial name
- NCT03433417
- Testing
- Cutera truSculpt
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Aneurysms
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
- Trial name
- STERLING (NCT03642639)
- Testing
- MICRUSFRAME and GALAXY coils
- Where
- 51 sites in United States, Belgium and 8 more
- Volunteers
- 723 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
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
Symptomatic Cervical Disc Disease
Performance of the Hedrocel(R) Cervical Fusion Device
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving…
- Trial name
- NCT00758758
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- 13 sites in United States
- Volunteers
- 231 people
- Sponsor
- Zimmer Biomet
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Femoral Arteriotomy Closure
MANTA Registry for Vascular Large-bore Closure
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for…
- Trial name
- MARVEL (NCT03330002)
- Testing
- CE-marked MANTA vascular closure device (VCD)
- Where
- 9 sites in Canada, Denmark and 3 more
- Volunteers
- 500 people
- Sponsor
- Essential Medical, Inc.
Rotator Cuff Tendinitis, Syndrome Rotator Cuff
Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
Rotator Cuff Syndrome is a commonly encountered musculoskeletal disorder in clinical practice, with an incidence ranging from 0.3% to 5.5%, and an annual prevalence of 0.5% to 7.4%.
- Conditions
- Rotator Cuff Tendinitis, Syndrome Rotator Cuff, Tendinopathy, Tendinoses, Rotator Cuff
- Trial name
- ROPIRAMED (NCT05489484)
- Testing
- MD-Shoulder Collagen Medical Device
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Guna S.p.a
Stress Urinary Incontinence
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking.
- Trial name
- NCT01770691
- Testing
- TIPI vaginal pessary
- Where
- Israel
- Volunteers
- 7 people
- Sponsor
- Assuta Hospital Systems
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.