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RECRUITINGNANCT06711965

Interactive Design of Patient-Specific Molds for Tissue Shaping

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 ...

Lead sponsor: M.D. Anderson Cancer Center•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Ashleigh M Francis, MD

CONTACT

713-563-4598 amfrancis@mdanderson.org

Sponsors

Lead Sponsor

M.D. Anderson Cancer Center

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 16, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment160

Start dateJul 2025

Last updatedApr 16, 2026

Condition

Locations shown

The University of Texas M. D. Anderson Cancer Center

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2026Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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