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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 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 12 participants.
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).
Interventions
- DEVICE Contour Profile Tissue Expander
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01222390
The ClinicalTrials.gov registry entry for NCT01222390 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Contour Profile Tissue Expander is the first listed.
NCT01222390 reports 0 study locations.
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.
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