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Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Breast Reconstruction

This study is looking at a new way to perform breast reconstruction after mastectomy using a single-port robotic system for a procedure called a DIEP flap. A DIEP flap uses tissue from your belly to rebuild the breast. Researchers want to see if using this robotic system is possible and safe for more patients. They will also look at things like complications, incision size, how well the flap works, pain after surgery, and your satisfaction with the results. You may be able to join if you are a woman aged 18 or older, are having a DIEP flap for breast reconstruction, and don't have certain health conditions or past abdominal surgeries. The study aims to enroll 4 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 4 women.
What's involved
You would have a preoperative consultation, undergo robotic-assisted DIEP flap surgery, and your medical records will be accessed for data collection.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study is measured from enrollment to the end of the procedure. Further follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222514

Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest

Recruiting
NAAges 18+InterventionalDevice feasibility
Vanderbilt University Medical Center
~4 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Single-Port Robotic System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of performing DIEP flap breast construction using a single port robotic system
Measured over From enrollment to the end of the procedure.

Conditions

DIEP Flap Breast Reconstruction

Explore related trials

Mammoplasty

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Galen Perdiks, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Emmanuel Giannas, MD
[email protected]
6154033398
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility of performing DIEP flap breast construction using a single port robotic systemFrom enrollment to the end of the procedure.

    This will be "Yes" if the following are true of the procedure: completed pedicle dissection using the robotic system, adequate pedicle dissected, and no intraoperative complication requiring conversion to the open approach.