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Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation

NCT07214220 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Intracranial Aneurysm

Interventions

PROCEDURE

Endovascular Intracranial aneurysm treatment

Endovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved.

DEVICE

nOCT imaging

During the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed.

Sponsors & Collaborators

  • Spryte Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2026-07-07
Completion
2029-02-28
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Canada

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 NCT07214220 on ClinicalTrials.gov