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New device aims to speed up breast reconstruction surgery

NCT ID NCT07670754

Symptom relief Sponsor: Duke University 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 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.

Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

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: * Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction * Patients who received mastectomies for oncologic or prophylactic indications * Patients receiving either immediate or delayed DIEP flap breast reconstruction * Age 18 or older at the time of patient consent and DIEP flap surgery Exclusion: * History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction * Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction * Under the age of 18 at the time of patient consent or DIEP flap surgery

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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