NCT06711965

Interactive Design of Patient-Specific Molds for Tissue Shaping

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mastectomy

Interventions

Type	Name	Description
PROCEDURE	Standard of care reconstruction	Participants will receive standard of care reconstruction
PROCEDURE	Surgery, Breast Mold	Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.

Timeline

• Start date: 2025-07-17
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2024-12-02
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States