Recruiting

Robotic Surgery

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07222514

Conditions

DIEP Flap Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single-Port Robotic System

Study Details

Brief summary:

The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life/satisfaction of breast procedures survey).

Conditions

DIEP Flap Breast Reconstruction

Study ID

NCT07222514

Start date

May 20, 2026

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Robotic Assisted DIEP Breast Reconstruction

This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction.

Interventions

Single-Port Robotic System

Utilizing the Single-Port robotic system for DIEP flap harvest has been previously described, but only in a small pilot study. The investigators plan to demonstrate the feasibility and safety of this approach on a larger cohort of patients.

Primary outcome measure

  • Feasibility of performing DIEP flap breast construction using a single port robotic system [ Time Frame: From enrollment to the end of the procedure. ]

Central Contacts and Locations

Central contacts

Emmanuel Giannas, MD

6154033398e.giannas@vumc.org

Jun Yao

jun.yao@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Julia Yao

615-343-8426jun.yao@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • DIEP flap breast reconstruction
  • Robotic Surgery
  • Breast Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-27.