Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07222514

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

Led by Vanderbilt University Medical Center · Updated on 2026-05-07

4

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

I

Intuitive Surgical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

J

Jordan Johnson, BS

CONTACT

R

Ricardo Torres Guzman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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