Clinical trials: Performance and Safety
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Hip Arthropathy, Orthopedic Disorder
Revision LR Femoral Stem for Hip Replacement
This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem
- Trial name
- NCT05810584
- Testing
- Revision LR femoral stem
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Limacorporate S.p.a
Functional Performance
Functional Performance and Acceptability Evaluation of the Miss Liberty Female Condom Compared to the FC2 Female Condom
The purpose of the study is to evaluate the functional performance and acceptability of the Miss Liberty female condom version 1 (Miss Liberty female condom), compared to the FC2 female condom.
- Trial name
- NCT06821152
- Testing
- Miss Liberty Condom, FC2 condom
- Where
- South Africa
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Peripheral Artery Disease (PAD)
A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled…
- Trial name
- SPARC (NCT07209085)
- Testing
- FastWave Artero™ Peripheral IVL System
- Volunteers
- 110 people
- Sponsor
- FastWave Medical
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative…
- Trial name
- NCT07117214
- Testing
- [68Ga]Ga-DWJ155
- Where
- Netherlands
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Propionic Acid for Multiple Sclerosis: Safety and Benefits
The purpose of this study is to explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS).
- Trial name
- Pro-MADAI (NCT07595081)
- Testing
- Propionic acid 1000 mg capsule
- Where
- Austria
- Volunteers
- 22 people
- Sponsor
- Salzburger Landeskliniken
Senile Cataract
Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery
- Trial name
- NCT06192901
- Where
- El Salvador
- Volunteers
- 8 people
- Sponsor
- Carl Zeiss Meditec AG
Chronic Heart Failure, Edema
AquaPass Device in Treatment of CHF Patients
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
- Conditions
- Chronic Heart Failure, Edema, CHF
- Trial name
- NCT05843201
- Testing
- The AquaPass System
- Where
- 2 sites in Israel
- Volunteers
- 18 people
- Sponsor
- AquaPass Medical Ltd.
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Overweight or Obesity
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia.
- Trial name
- SHINE (NCT06087822)
- Testing
- IMD SiPore21®
- Where
- 27 sites in Poland, Romania and 1 more
- Volunteers
- 318 people
- Sponsor
- Sigrid Therapeutics AB
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck.
- Trial name
- POPPY (NCT03813836)
- Testing
- Pembrolizumab
- Where
- 12 sites in United Kingdom
- Volunteers
- 63 people
- Sponsor
- University College, London
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- PROTONTO (NCT04542577)
- Where
- 2 sites in Germany
- Volunteers
- 208 people
- Sponsor
- Aesculap AG
Vestibulopathy, Moderate to Severe Hearing Loss
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and…
- Conditions
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits
- Trial name
- BionicVEST2 (NCT06805175)
- Testing
- vestibular implant
- Where
- 3 sites in Belgium, Spain
- Volunteers
- 18 people
- Sponsor
- Cochlear
Cerebrovascular Accident
Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation
This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients.
- Trial name
- NCT00050128
- Testing
- rTMS, Magstim
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Fluid Responsiveness Predictability, Hemodynamic Monitoring
Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients
The goal of this clinical trial is to learn if a new medical device called ResQ works to predict fluid needs in adults undergoing surgery under general anesthesia.
- Conditions
- Fluid Responsiveness Predictability, Hemodynamic Monitoring, Anesthesia, General
- Trial name
- NCT07516470
- Testing
- Biological Signal Processing Device for Acoustic Variability Index, Patient monitor for pulse pressure variation, Hemodynamic monitor for cardiac Output and stroke volume variation
- Where
- South Korea
- Volunteers
- 122 people
- Sponsor
- Signal House Co., Ltd.
Lung Cancer
Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.
The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system.
- Trial name
- AURORA (NCT07291973)
- Testing
- Microwave Ablation
- Where
- 3 sites in France, United Kingdom
- Volunteers
- 43 people
- Sponsor
- Endowave Ltd.
Obesity
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
- Trial name
- NCT01422941
- Testing
- CAVU Attune Device
- Where
- 2 sites in Australia
- Volunteers
- 40 people
- Sponsor
- Cavu Medical, Inc.
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
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