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

NCT07222514 | Recruiting FDA Device

• 1 other identifier: 250009
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

DIEP flap breast reconstruction; Robotic Surgery; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Feasibility of performing DIEP flap breast construction using a single port robotic system

  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.

  From enrollment to the end of the procedure.

Secondary Outcomes (9)

• Complication Rates

  Through study completion, an average of 1 year.

• Fascial Incision Length

  Through study completion, an average of 1 year.

• Flap Success Rate

  From procedure to 7 days post operation.

• Operative Time

  From procedure start to procedure completion.

• Pain Level

  From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.

Study Arms (1)

Robotic Assisted DIEP Breast Reconstruction

EXPERIMENTAL

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

Device: Single-Port Robotic System

Interventions

Single-Port Robotic System DEVICE

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.

Robotic Assisted DIEP Breast Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (4)

• Roy N, Alessandro CJ, Ibelli TJ, Akhavan AA, Sharaf JM, Rabinovitch D, Henderson PW, Yao A. The Expanding Utility of Robotic-Assisted Flap Harvest in Autologous Breast Reconstruction: A Systematic Review. J Clin Med. 2023 Jul 27;12(15):4951. doi: 10.3390/jcm12154951.

  PMID: 37568353 BACKGROUND

• Tsai CY, Kim BS, Kuo WL, Liu KH, Chang TN, Cheong DC, Huang JJ. Novel Port Placement in Robot-Assisted DIEP Flap Harvest Improves Visibility and Bilateral DIEP Access: Early Controlled Cohort Study. Plast Reconstr Surg. 2023 Oct 1;152(4):590e-595e. doi: 10.1097/PRS.0000000000010470. Epub 2023 Mar 30.

  PMID: 36995211 BACKGROUND

• Lee MJ, Won J, Song SY, Park HS, Kim JY, Shin HJ, Kwon YI, Lee DW, Kim NY. Clinical outcomes following robotic versus conventional DIEP flap in breast reconstruction: A retrospective matched study. Front Oncol. 2022 Sep 14;12:989231. doi: 10.3389/fonc.2022.989231. eCollection 2022.

  PMID: 36185209 BACKGROUND

• Choi JH, Song SY, Park HS, Kim CH, Kim JY, Lew DH, Roh TS, Lee DW. Robotic DIEP Flap Harvest through a Totally Extraperitoneal Approach Using a Single-Port Surgical Robotic System. Plast Reconstr Surg. 2021 Aug 1;148(2):304-307. doi: 10.1097/PRS.0000000000008181.

  PMID: 34398082 BACKGROUND

Study Officials

• Galen Perdiks, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Johnson, BS

CONTACT

7138559208; jordan.johnson.1@vumc.org

Ricardo Torres Guzman, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor, Department of Plastic Surgery

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 30, 2025
• Study Start (Estimated): May 23, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)