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Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

NCT01222390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-04-06

Study results available
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Summary

The purpose of this study is to explore the volume change and location of volume change in reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to investigate the safety of using CPX3® in tissue-expander breast reconstruction via a comparison between the complication rates that result from this study and the complication rates with the use of other tissue expander types, as reported in the literature. We also hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and lower breast volume change and location of this volume change in the reconstructed breast. Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole volume expansion when compared to lower pole volume expansion from round, standard tissue expanders as reported in the literature. Additionally, we hypothesize that CPX3, in combination with human acellular dermis, is less prone to complications than standard tissue expanders (again, as reported in the literature).

Conditions

  • Contour Irregularity of Reconstructed Breast

Interventions

DEVICE

Contour Profile Tissue Expander

The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.

Sponsors & Collaborators

Principal Investigators

  • John YS Kim, MD, MA · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-07-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222390 on ClinicalTrials.gov