Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Funder type Industry (pharma, biotech, devices)
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Cranioplasty, Craniofacial Abnormalities
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and…
- Conditions
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- Trial name
- NCT05362370
- Testing
- Stryker's PEEK Customized Implant
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 99 people
- Sponsor
- Stryker Craniomaxillofacial
Heart Failure
C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily…
- Trial name
- NCT01176370
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Nuwellis, Inc.
Bowel Dysfunction
En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the…
- Trial name
- NCT06377280
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Wellspect HealthCare
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
Obstructive Sleep Apnoea (OSA)
Assessment of the Performance of a New Reduced Noise Mask Vent
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent.
- Trial name
- NCT01575210
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 31 people
- Sponsor
- ResMed
Fractures, Bone
Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use…
- Trial name
- MJ-Flex (NCT06412913)
- Testing
- MJ-Flex The New Metaizeau Nail
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Orthofix s.r.l.
Prostate Cancer
Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])
This is an open-label, nonrandomized, multicenter study conducted in two sequential parts: an initial Phase 2 Dose Optimization Period followed by the Phase 3 Diagnostic Performance Period.
- Trial name
- SPARROW (NCT07831824)
- Testing
- [68Ga]-LNTH-2401
- Where
- United States
- Volunteers
- 408 people
- Sponsor
- Lantheus Medical Imaging
Partial-thickness Burn
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial…
- Trial name
- NCT04839523
- Testing
- Exufiber, Exufiber Ag+
- Where
- 6 sites in United States
- Volunteers
- 44 people
- Sponsor
- Molnlycke Health Care AB
Foot Drop, Thigh Muscles Weakness (Hamstrings or Quadriceps)
Evaluation of the Safety and Performance of the NESS L300 Plus System
The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease.
- Conditions
- Foot Drop, Thigh Muscles Weakness (Hamstrings or Quadriceps), Upper Motor Neuron Injury or Disease
- Trial name
- L300Plus (NCT01237860)
- Testing
- NESS L300 Plus System
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Bioness Inc
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.
Hypertension
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7…
- Trial name
- OBPM_PANDA2026 (NCT07507903)
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Periorbital Wrinkles
Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
This is a prospective, interventional, evaluator-blinded, multi-center clinical study designed to assess the safety and performance of the Epicare fractional nano-thulium (Tm:YAP 1938 nm) laser system for the treatment of…
- Trial name
- NCT07114562
- Testing
- Epicare
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Laser team Ltd
Full Thickness Rotator Cuff Tear
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears.
- Trial name
- NCT01256242
- Testing
- Augment Rotator Cuff, Standard Suture Repair
- Where
- 4 sites in Canada
- Volunteers
- 31 people
- Sponsor
- BioMimetic Therapeutics
Epistaxis
Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting
Between 10 and 12% of the general population suffers from epistaxis, out of which 10% would need to be medically managed. Most of patients treated for epistaxis are managed through emergency departments.
- Trial name
- BATSI (NCT03912051)
- Testing
- asymmetric balloon
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Dianosic
End Stage Renal Disease (ESRD)
Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)
Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD).
- Trial name
- NCT03812679
- Testing
- AMIA APD Solution Generation System
- Where
- 11 sites in United States
- Volunteers
- 22 people
- Sponsor
- Vantive Health LLC
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency
- Trial name
- NCT06091566
- Testing
- UCon-Bar
- Where
- 3 sites in Denmark
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH
Influenza
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
- Trial name
- NCT03248960
- Testing
- iTreat Flu A+B Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 8 sites in Australia
- Volunteers
- 381 people
- Sponsor
- Ellume Pty Ltd
Ventricular Tachycardia, Ventricular Fibrillation
Unpinning Termination Therapy for VT/VF
This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators.
- Trial name
- NCT03871231
- Testing
- Unpinning Termination Therapy
- Where
- 4 sites in Australia
- Volunteers
- 8 people
- Sponsor
- Cardialen, Inc.
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