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Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter

NCT06078878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-30

No results posted yet for this study

Summary

This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.

Conditions

  • Anatomy

Interventions

DEVICE

HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

Subjects undergo HF-OCT imaging of the desired intravascular segement

Sponsors & Collaborators

  • Gentuity, LLC

    lead INDUSTRY

Principal Investigators

  • Pedro Lylyk, MD · Clínica La Sagrada Familia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078878 on ClinicalTrials.gov