Interactive Design of Patient-Specific Molds for Tissue Shaping

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2030-08-01

Brief Summary

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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.

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Detailed Description

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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

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Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intraoperative Use of 3D Printed Breast Mold

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Group Type EXPERIMENTAL

Standard of care reconstruction

Intervention Type PROCEDURE

Participants will receive standard of care reconstruction

Standard of Care Reconstruction

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Group Type EXPERIMENTAL

Surgery, Breast Mold

Intervention Type PROCEDURE

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

Interventions

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Standard of care reconstruction

Participants will receive standard of care reconstruction

Intervention Type PROCEDURE

Surgery, Breast Mold

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No