The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY. (FAST)

August 7, 2026 updated by: Jacobs institute
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The FAST study is an Early Feasibility Study (EFS), prospective, open-label, single-arm, unblinded, fifteen (n=15) patient investigation

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has a single untreated target IA.

Exclusion Criteria:

  • Subject with anatomy not appropriate for endovascular treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT
Device: Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy.
medial device intervention for aneurysm cerebral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A thromboembolic event in the territory supplied by the treated artery.
Time Frame: 12 months
A thromboembolic event in the territory supplied by the treated artery.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobs institute

Collaborators

University at Buffalo

Investigators

  • Principal Investigator: Elad Dr. Levy, MD, Jacobs institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is currently undecided.

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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