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

NCT ID NCT03757793

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

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.

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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

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Locations

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

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