Interactive Design of Patient-Specific Molds for Tissue Shaping
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients 18 years of age or older
• Patients who are willing and able to provide informed consent
• Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)
Locations
United States
Texas
The University of Texas M. D. Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Ashleigh M Francis, MD
amfrancis@mdanderson.org
713-563-4598
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 160
Treatments
Experimental: Intraoperative Use of 3D Printed Breast Mold
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
Experimental: Standard of Care Reconstruction
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center