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NCT03784859 · ClinicalTrials.gov registry record
Tissue Expansion in Breast Reconstruction Without Drains
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 5
- Enrollment target
NCT03784859: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT03784859 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03784859 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 5 participants
- Enrollment target
Study Summary
The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.
Primary Outcome
The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.
Interventions
- DEVICE Insertion of Tissue Expander with Fluid Reservoir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-02-25 |
| Est. Completion | 2020-10-02 |
What the finished NCT03784859 record still lists
NCT03784859 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Insertion of Tissue Expander with Fluid Reservoir is the first listed.
NCT03784859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03784859 about?
NCT03784859 is a clinical study titled "Tissue Expansion in Breast Reconstruction Without Drains". The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration....
What is the current status of trial NCT03784859?
This trial is currently completed. The enrollment target is 5 participants. The study started on 2019-02-25. Estimated completion is 2020-10-02.
What interventions are being tested in trial NCT03784859?
The interventions under investigation include: Insertion of Tissue Expander with Fluid Reservoir (DEVICE).
Who is sponsoring clinical trial NCT03784859?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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