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NCT06711965 | NOT YET RECRUITING | Mastectomy

Interactive Design of Patient-Specific Molds for Tissue Shaping
Sponsor:

M.D. Anderson Cancer Center

Brief 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.

Condition or disease

Mastectomy

Intervention/treatment

Standard of care reconstruction

Surgery, Breast Mold

Phase

NA

Detailed Description:

Primary Objective: To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms. Secondary Objectives: To assess the total number of times the mold was used by the surgeons in the intervention group. To compare the intraoperative time for shaping tissue in control versus intervention group. To collect information on the type of revisions for aesthetic purposes required in control versus intervention group. To assess the number and type of complications experienced in control versus intervention group.

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Interactive Design of Patient-Specific Molds for Tissue Shaping
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2028-08-01
Estimated Study Completion Date : 2030-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients 18 years of age or older
  • 2. Patients who are willing and able to provide informed consent
  • 3. 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 Criteria
  • 1. Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
  • 2. Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
  • 3. Patients undergoing neoadjuvant radiation
Interactive Design of Patient-Specific Molds for Tissue Shaping

Location Details

NCT06711965

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030