Status:
NOT_YET_RECRUITING
Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Intuitive Surgical
Conditions:
DIEP Flap Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
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,...
Detailed Description
This project will be conducted at Vanderbilt University Medical Center. Patients scheduled for a DIEP flap procedure will be recruited through screening of the electronic medical records (EMR) to eval...
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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT07222514
Start Date
October 1 2025
End Date
December 1 2027
Last Update
October 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232