Clinical trials: Medical Device Complication
Stress Urinary Incontinence
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden.
- Trial name
- NCT03186651
- Testing
- TVS
- Where
- 4 sites in Sweden
- Volunteers
- 97 people
- Sponsor
- Invent Medic Sweden AB
Vaginal Atrophy
Real-world Evidence Study on the Performance and Safety of Halova Ovules
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy…
- Trial name
- NCT05654610
- Testing
- Halova
- Where
- 14 sites in Romania
- Volunteers
- 249 people
- Sponsor
- Perfect Care Distribution
Diabetic Retinopathy, Diabetic Macular Edema
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through…
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy
- Trial name
- OPHTAI-EVAL (NCT05752045)
- Testing
- Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
- Where
- 12 sites in France
- Volunteers
- 1,389 people
- Sponsor
- Evolucare Technologies
Vaginitis, Bacterial Vaginosis
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora.
- Trial name
- NCT05652959
- Testing
- Cerviron®
- Where
- 10 sites in Romania
- Volunteers
- 111 people
- Sponsor
- Perfect Care Distribution
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Oral Mucositis, Stem Cell Transplant Complications
Study of a New Medical Device for Oral Mucositis
This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment.
- Trial name
- MDOM (NCT05104268)
- Testing
- Bocaliner
- Where
- Armenia
- Sponsor
- E2Bio Life Sciences, LLC
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Trial name
- NCT05782296
- Testing
- TrueLabor
- Where
- 3 sites in United States, Israel
- Volunteers
- 80 people
- Sponsor
- OB-Tools Ltd.
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
Intravenous Access, Medical Device
Safe-Infusion Study
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or…
- Trial name
- NCT06727240
- Testing
- Intervention
- Where
- 2 sites in Portugal, Spain
- Volunteers
- 548 people
- Sponsor
- Interlinked AB
Arthroplasty Complications, Osteo Arthritis Shoulders
Comprehensive SRS Regenerex Tissue Attachment
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb…
- Trial name
- NCT06615739
- Testing
- Regenerex Tissue Attachment Augments
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Zimmer Biomet
Chronic Kidney Diseases, Diabetes
KidneYou - Innovative Digital Therapy
The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness…
- Conditions
- Chronic Kidney Diseases, Diabetes, Arterial Hypertension, Chronic Glomerulonephritis
- Trial name
- NCT05286632
- Testing
- KidneYou APP
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Advice Pharma Group srl
Pregnancy, Ectopic
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
In this trial researchers want to learn more about the occurrence of pregnancies growing outside the womb over the last decade (2009-2018) and the potential risk factors associated with pregnancies growing outside the womb.
- Trial name
- NCT03670784
- Testing
- No intervention
- Where
- United States
- Volunteers
- 3,922,877 people
- Sponsor
- Bayer
Gastrointestinal Complication
Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII).
- Trial name
- NCT04880473
- Testing
- PrevisEA device
- Where
- 8 sites in United States
- Volunteers
- 400 people
- Sponsor
- Entac Medical Inc.
Kidney Stones, Urolithiasis
DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Trial name
- DISON I (NCT07712861)
- Testing
- RIRS with Investigational Device
- Where
- 5 sites in Argentina, Canada and 3 more
- Volunteers
- 75 people
- Sponsor
- Ventaris Surgical Incorporated
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.
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
Pulmonary Embolism, Medical Device Complication
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis
- Trial name
- NCT02917135
- Testing
- Angel® Catheter
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- BiO2 Medical
Chronic Kidney Diseases
Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease.
- Trial name
- NCT05827588
- Testing
- AWAK PD
- Where
- Singapore
- Volunteers
- 12 people
- Sponsor
- AWAK Technologies Pte Ltd
IV Catheter-Related Infection or Complication
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no…
- Trial name
- DIPPER (NCT04469218)
- Testing
- SafeBreak Vascular
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Lineus Medical
Bacterial Vaginosis, Candidal Vaginitis
Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
This is a randomized, double-blind, placebo-controlled, two-arm parallel-group clinical study evaluating the efficacy and safety of INTIMIQUE OVULI, a Class IIa vaginal medical device, in adult women (18-60 years) diagnosed with…
- Trial name
- ROVUL-25 (NCT07703241)
- Testing
- Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- ROELMI HPC