NCT06078878

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Gentuity, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.

Conditions

• Anatomy

Interventions

Type	Name	Description
DEVICE	HF-OCT Imaging System with Vis-M Micro-Imaging Catheter	Subjects undergo HF-OCT imaging of the desired intravascular segement

Timeline

• Start date: 2023-02-13
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-10-12
• Last updated: 2025-03-30

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study