Clinical trials: Lesion
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Colorectal Lesions
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.
- Trial name
- NCT01269372
- Testing
- PillCam Colon 2, Colonoscopy
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Soft Tissue Lesion
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting.
- Trial name
- PROPEL (NCT05851430)
- Testing
- PEF ablation
- Where
- 11 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Galvanize Therapeutics, Inc.
Pigmentation
Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions
The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.
- Trial name
- NCT04493021
- Testing
- Dermal Cooling System
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- R2 Dermatology
Bone Lesion, Bone Tumor
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.
- Conditions
- Bone Lesion, Bone Tumor, Bone Infection
- Trial name
- NCT05732558
- Testing
- 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
- Where
- Italy
- Volunteers
- 16 people
- Sponsor
- R.A.W. - S.R.L.
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
Cardiogenic Shock, Acute Myocardial Infarction
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and…
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Decompensated Heart Failure
- Trial name
- NCT07825363
- Testing
- NIRSense Tissue Oximetry Sensor System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NIRSense Inc.
Peripheral Artery Disease (PAD)
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries.
- Trial name
- SELECT (NCT06605209)
- Testing
- Peripheral Balloon-Expandable Covered Stent System
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Knee Injury
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
- Trial name
- NCT00793104
- Testing
- Placement of allograft CR Plug in primary injury site
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- RTI Surgical
Parkinson's Disease
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar…
- Trial name
- NCT02230904
- Testing
- Rotigotine (Test product PR 2.3.1), Rotigotine (Reference product PR 2.1.1)
- Where
- 11 sites in Germany
- Volunteers
- 57 people
- Sponsor
- UCB BIOSCIENCES GmbH
Coronary Artery Disease
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
- Trial name
- PLATINUM LL (NCT01500434)
- Testing
- PROMUS Element Coronary Stent System, Aspirin, Thienopyridine
- Where
- 30 sites in United States, Australia and 5 more
- Volunteers
- 102 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Choroidal Melanoma, Indeterminate Lesions
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to…
- Trial name
- IL (NCT05266430)
- Testing
- Standard of Care, AU-011
- Where
- 7 sites in United States
- Volunteers
- 2 people
- Sponsor
- Aura Biosciences
Brain Lesion (General)
Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with diffuse brain lesions and clinical outcomes.
- Trial name
- NCT01453777
- Testing
- harvesting and implantation of adipose derived stem cells
- Where
- Mexico
- Sponsor
- Ageless Regenerative Institute
Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis
A Clinical Study of the Dynesys(R) Spinal System
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
- Conditions
- Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis, Stenosing Lesion.
- Trial name
- NCT00759057
- Testing
- Posterior Pedicle Screw System
- Where
- 26 sites in United States
- Volunteers
- 399 people
- Sponsor
- Zimmer Biomet
Cardiovascular Diseases
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System
The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries…
- Trial name
- NCT00497367
- Testing
- Percutaneous Coronary Intervention (PCI) TAXUS Petal
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 28 people
- Sponsor
- Boston Scientific Corporation
Healthy
Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone.
- Trial name
- NCT01353534
- Testing
- A/H5N1 Antigen, Vaccine Enhancement Patch
- Where
- 5 sites in Austria, Belgium
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Cervical Cancer
Biop System's Safety and Performance
Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy
- Trial name
- NCT04232865
- Testing
- Biop System
- Volunteers
- 320 people
- Sponsor
- BIOP Medical
Breast Cancer, Breast Lesions
Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms
This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence…
- Conditions
- Breast Cancer, Breast Lesions, Breast Mass
- Trial name
- NCT03706534
- Testing
- Ultrasound Image review with CADe, Ultrasound Image review with CADx, Ultrasound Image manual review
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Samsung Medison
Vascular Diseases
Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair
The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device.
- Trial name
- NCT03173703
- Testing
- Implant the XenoSure patch, Repair/reconstruction of the diseased vessel, Implant the Vascular-Patch
- Where
- China
- Volunteers
- 144 people
- Sponsor
- LeMaitre Vascular
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