Clinical trial · Interventional
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Contour Irregularity of Reconstructed Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contour Profile Tissue Expander | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contour Profile Tissue Exander
- description
- Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
- interventionNames
- Device: Contour Profile Tissue Expander
Primary outcomes (1)
- measure
- Breast Projection
- timeFrame
- 1.5 years
- description
- The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to undergo unilateral or bilateral mastectomies for treatment of breast cancer with immediate tissue expander reconstruction Exclusion Criteria: * Patients who have had previous immediate non-expander based breast reconstruction * Patients who have had delayed secondary flap surgery (replacing expander with autogenous tissue) * Patients who have pacemakers and/or defibrillators which are not compatible with CPX3
References
Publications (3)
- RESULTHirsch EM, Seth AK, Dumanian GA, Kim JYS, Mustoe TA, Galiano RD, Fine NA. Outcomes of tissue expander/implant breast reconstruction in the setting of prereconstruction radiation. Plast Reconstr Surg. 2012 Feb;129(2):354-361. doi: 10.1097/PRS.0b013e31823ae8b1. PMID 22286418
- RESULTMioton LM, Smetona JT, Hanwright PJ, Seth AK, Wang E, Bilimoria KY, Gaido J, Fine NA, Kim JY. Comparing thirty-day outcomes in prosthetic and autologous breast reconstruction: a multivariate analysis of 13,082 patients? J Plast Reconstr Aesthet Surg. 2013 Jul;66(7):917-25. doi: 10.1016/j.bjps.2013.03.009. Epub 2013 Apr 4. PMID 23562485
- RESULTNahabedian MY, Galdino G. Symmetrical breast reconstruction: is there a role for three-dimensional digital photography? Plast Reconstr Surg. 2003 Nov;112(6):1582-90. doi: 10.1097/01.PRS.0000085818.54980.C4. PMID 14578788