Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device aims to spot failing breast flaps before it's too late

NCT ID NCT03757793

Knowledge-focused Sponsor: University Hospital, Antwerp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a near-infrared spectroscopy device could detect early signs of poor blood flow in tissue flaps used for breast reconstruction after mastectomy. The device was placed on the reconstructed breast and compared to standard physical exams. Only 18 people took part before the study was stopped early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FORE-SIGHT ELITE monitor (near-infrared spectroscopy device)
What this could lead to
If successful, this could provide a non-invasive way to catch blood flow issues early after breast reconstruction, potentially reducing complications.
What could go wrong
The trial was terminated early with only 18 participants, so results are limited. The device may not be more reliable than standard physical exams.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Sep 2018

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women, over 18 years, undergoing unilateral or bilateral DIEP flap procedure

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap procedure. Exclusion Criteria: * refusal of written informed consent * redo-surgery * known history of allergy to adhesives

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast reconstruction are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

limb ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast reconstruction Flap ischemia Mastectomy

Contacts and locations

Locations

  • University hospital Antwerp

    Edegem, Antwerp, 2650, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.