RecruitingNot ApplicableNCT06711965

Interactive Design of Patient-Specific Molds for Tissue Shaping


Sponsor

M.D. Anderson Cancer Center

Enrollment

160 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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)

Exclusion Criteria3

  • Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
  • Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
  • Patients undergoing neoadjuvant radiation

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Interventions

PROCEDUREStandard of care reconstruction

Participants will receive standard of care reconstruction

PROCEDURESurgery, Breast Mold

Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT06711965


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