Interactive Design of Patient-Specific Molds for Tissue Shaping
ConditionMastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Standard of care reconstruction
Procedure/SurgeryParticipants will receive standard of care reconstruction
Surgery, Breast Mold
Procedure/SurgeryParticipants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Intraoperative Use of 3D Printed Breast MoldExperimental treatment 1 intervention
Group B: Standard of Care ReconstructionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse eEents (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov