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

• Sponsor: Gentuity, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06078878
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anatomy	Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
• Actual Study Start Date: Feb 13, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurovascular Imaging Use of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter ("Gentuity Neurovascular Imaging System") as a diagnostic tool for intravascular imaging in the cerebrovasculature.	Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter; Subjects undergo HF-OCT imaging of the desired intravascular segement

Outcome Measures

Primary Outcome Measures

1. Safety [7 days]

   Incidence and severity of device-related adverse events.

Secondary Outcome Measures

1. Clinical performance [1 day]

   Operator evaluation of performance via Likert scale.

2. Technical performance [1 day]

   Clear image length (CIL) of the vessel

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure

• Patients that present with a Modified Rankin Score (mRS) ≤3

• Patients 18 years of age or older

• Patients willing and able to provide written informed consent to participate in evaluation

Exclusion Criteria:

• Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk

• Pregnant

• Patient has a known hypersensitivity to contrast media

• Patients undergoing an urgent or emergent neurointerventional procedure

• Patients that present with a Modified Rankin Score (mRS) ≥4

• Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage

• Participation in another clinical trial of an investigational drug or device

• Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica La Sagrada Familia	Buenos Aires		Argentina	C1428ARJ

Sponsors and Collaborators

• Gentuity, LLC

Investigators

• Principal Investigator: Pedro Lylyk, MD, Clínica La Sagrada Familia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gentuity, LLC
• ClinicalTrials.gov Identifier: NCT06078878
• Other Study ID Numbers: 003818
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Oct 12, 2023