Vis-Rx Post-Market Evaluation
NCT04533503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 257
Last updated 2025-03-20
Summary
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
Conditions
Interventions
- DEVICE
-
HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Sponsors & Collaborators
-
Gentuity, LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-22
- Primary Completion
- 2023-01-25
- Completion
- 2023-01-25
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Volumetric Impedance to Guide Stroke Response
NCT03767842 ·Status: UNKNOWN
-
A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
NCT01076296 ·Status: COMPLETED
-
COVID-19 Remote Monitoring
NCT04350476 ·Status: WITHDRAWN ·Phase: NA
-
AutoMatic disPERsion Tagging Function Preliminary Evaluation
NCT05362656 ·Status: COMPLETED ·Phase: NA
-
Validity and Reliability of Optical Heart Rate Sensors
NCT05525000 ·Status: COMPLETED ·Phase: NA
-
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
NCT02756338 ·Status: COMPLETED
-
Prospective Registry on User Experience With The Mapping System For Ablation Procedures
NCT02698670 ·Status: COMPLETED
-
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
NCT02975050 ·Status: COMPLETED
-
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
NCT06147336 ·Status: RECRUITING ·Phase: NA
-
Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
NCT01808053 ·Status: COMPLETED
-
Portrait Mobile Monitoring Solution V2.0 External Evaluation
NCT07309809 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
NCT03975725 ·Status: UNKNOWN ·Phase: NA
-
Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
NCT03589716 ·Status: COMPLETED ·Phase: NA
-
Hexoskin Medical System - ECG Performance Testing
NCT05970328 ·Status: COMPLETED
-
Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
NCT03554564 ·Status: COMPLETED ·Phase: NA
-
Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology in Covid-19
NCT04695821 ·Status: UNKNOWN ·Phase: NA
-
Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)
NCT05452356 ·Status: RECRUITING
-
Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography
NCT06829615 ·Status: COMPLETED ·Phase: NA
-
Data Collection of Arterial Line Waveform and BP Values
NCT04510753 ·Status: COMPLETED
-
Performance Assessment of a Remote Patient Monitoring Device
NCT02570906 ·Status: COMPLETED
-
Validation of a Sensor for Non-Invasive Measurements
NCT03463148 ·Status: COMPLETED
-
Assessment of Remote Vital Signs for Telemedicine Applications
NCT04820387 ·Status: ACTIVE_NOT_RECRUITING
-
Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology
NCT04693091 ·Status: UNKNOWN ·Phase: NA
-
Non-contact ECG Sensor System for COVID19
NCT04341506 ·Status: UNKNOWN
-
Vital Sign Comparison Between Lifelight and Standard of Care - Development
NCT04003662 ·Status: COMPLETED