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NCT01222390 · ClinicalTrials.gov registry record · NA
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT01222390: Completed NA study, sponsored by Northwestern University.
NCT01222390 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222390, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DEVICE Contour Profile Tissue Expander
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01222390 record still lists
NCT01222390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Contour Profile Tissue Expander is the first listed.
NCT01222390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01222390 about?
NCT01222390 is a clinical study titled "Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change". 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...
What is the current status of trial NCT01222390?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2010-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01222390?
The interventions under investigation include: Contour Profile Tissue Expander (DEVICE).
Who is sponsoring clinical trial NCT01222390?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01222390's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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