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Robot-Assisted breast reconstruction: smaller incisions, big hopes

NCT ID NCT07222514

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a single-port robotic system can safely harvest tissue from the abdomen for breast reconstruction. Four women who need DIEP flap reconstruction will undergo the procedure. The goal is to see if the robotic approach is feasible and leads to fewer complications and smaller scars.

What this could mean

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

Active substance
Single-Port Robotic System
What this could lead to
If successful, this could make DIEP flap breast reconstruction less invasive, with smaller incisions and potentially faster recovery.
What could go wrong
This is a very early feasibility study with only 4 participants, so results may not apply broadly. Risks include surgical complications like flap failure or infection.

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 4 people

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

Started

May 2026

Expected to finish

Dec 2028

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 Criteria: * Female patients aged ≥18 years. * Candidates for unilateral or bilateral breast reconstruction using a DIEP flap. * No contraindications for general anesthesia or robotic surgery. * Patients with adequate abdominal donor tissue for DIEP flap harvest. Exclusion Criteria: * History of prior abdominal surgery that significantly compromises perforator vessel integrity. * Pregnant woman. * Prisoners. * BMI \> 35, as measured during the preoperative evaluation. * Presence of comorbidities that contraindicate elective surgery. * Active cancer other than breast cancer at the time of evaluation. * Active metastatic disease confirmed via imaging or biopsy. * Inability to comply with follow-up visits. * The research team decides to exclude the patient.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Diep flap breast reconstruction

How to take part

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

  1. The places running it

    1 site. 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

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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