New device aims to speed up breast reconstruction surgery

NCT ID NCT07670754

Not yet recruiting Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a device called ORASIS, which helps keep the surgical area clean during DIEP flap breast reconstruction. The device automatically removes fluid and smoke, so the surgeon can work without pausing. The trial will include 30 women who have had a mastectomy and are getting DIEP flap reconstruction. Researchers will measure how long the surgery takes and how often the surgeon has to stop.

What this could mean

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

Active substance: ORASIS device (a dual irrigation and suction tool used during microsurgery)
What this could lead to: If it works, this could make DIEP flap breast reconstruction surgeries faster and more efficient, potentially reducing complications.
What could go wrong: This is a very small early-stage trial with only 30 participants, so results may not apply widely. The device is not yet FDA registered, and the study focuses on surgical process, not long-term patient outcomes.

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.

breast cancer breast neoplasm

As listed by the trial registrant

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

BREAST CANCER BREAST RECONSTRUCTION DIEP FLAP

Contacts and locations

Locations

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States

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