Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation

Conditions

• Intracranial Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Endovascular Intracranial aneurysm treatment — PROCEDURE
  Endovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved.
• nOCT imaging — DEVICE
  During the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed.

Study Details

This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices. The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing. The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.

Key Dates

Start date

Feb 25, 2026

Status verified

May 2026

Primary completion

Jul 7, 2026

Completion

Feb 28, 2029

Study Design

Enrollment

67 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Single arm: Use of nOCT during treatment and follow-up
  Use of nOCT during intracranial aneurysm treatment and subsequent follow-up

Primary Outcome Measure

Safety - Adverse Events [ Time Frame: peri-procedural ]

Locations (6)

Find similar trials in Jacksonville, FL

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