Clinical trials: Performance and Safety
Incontinence, Urge
T-DOC® NXT Clinical Investigation
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
- Trial name
- NCT03615001
- Testing
- TDOC NXT
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
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
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Substance Use Disorder (SUD)
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances.
- Trial name
- NCT06629740
- Testing
- Measurements with a eHealth system
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Refractive Errors
Safety and Effectiveness of the Qualis Contact Lens
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
- Trial name
- NCT04295499
- Testing
- soft (hydrophilic) contact lens
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Unicon Optical Co. Ltd.
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
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
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…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Heart Failure
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.
- Trial name
- NCT01542502
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Virginia Commonwealth University
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
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
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.
Cataract
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
- Trial name
- NCT04224155
- Testing
- enVista MX60EFH trifocal intraocular lenses (IOLs), enVista MX60E monofocal intraocular lenses (IOLs)
- Where
- 9 sites in Canada
- Volunteers
- 165 people
- Sponsor
- Bausch & Lomb Incorporated
Coronary Artery Disease
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices
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
Overactive Bladder, Fecal Incontinence
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
- Conditions
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- Trial name
- ELITE (NCT04506866)
- Testing
- InterStim Micro
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 148 people
- Sponsor
- MedtronicNeuro
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS