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NCT00639106 · ClinicalTrials.gov registry record · Phase 3
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
A Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
NCT00639106: Completed Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00639106 is a Phase 3 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00639106, a Phase 3 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
Study Summary
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander. AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
Interventions
- PROCEDURE Alloderm, Questionnaires
- PROCEDURE Without ALLODERM, Questionnaires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2008-03 |
| Est. Completion | 2018-10 |
| Phase | Phase 3 |
What the finished NCT00639106 record still lists
NCT00639106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Alloderm, Questionnaires is the first listed.
NCT00639106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00639106 about?
NCT00639106 is a clinical study titled "Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial". Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually...
What is the current status of trial NCT00639106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2008-03. Estimated completion is 2018-10.
What interventions are being tested in trial NCT00639106?
The interventions under investigation include: Alloderm, Questionnaires (PROCEDURE), Without ALLODERM, Questionnaires (PROCEDURE).
Who is sponsoring clinical trial NCT00639106?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00639106's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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