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

Conditions

• DIEP Flap Breast Reconstruction

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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).

Key Dates

Start date

May 20, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

4 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Robotic Assisted DIEP Breast Reconstruction
  This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction.

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

• Emmanuel Giannas, MD
  6154033398
  [email protected]
• Jun Yao
  [email protected]

Locations (1)

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