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NCT05975372 · ClinicalTrials.gov registry record · NA
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
A NA study of Implant Based Breast Reconstruction and Tissue Expansion, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05975372 is a NA study of Implant Based Breast Reconstruction and Tissue Expansion that is actively recruiting participants, run by Stanford University. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05975372, a NA study of Implant Based Breast Reconstruction and Tissue Expansion, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/ augmentation compared to standard tissue expansion methods.
Conditions Studied
Interventions
- DEVICE Blossom tissue expander
- DEVICE Standard tissue expansion
Study Locations (1)
California
- Stanford Hospital and Clinics - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-11-17 |
| Est. Completion | 2026-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05975372
The ClinicalTrials.gov registry entry for NCT05975372 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Implant Based Breast Reconstruction appearing as the primary indexed condition, and to 2 interventions - of which Blossom tissue expander is the first listed.
NCT05975372 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05975372 about?
NCT05975372 is a clinical study titled "Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction". The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be unco...
What is the current status of trial NCT05975372?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-11-17. Estimated completion is 2026-07.
What conditions does trial NCT05975372 study?
This clinical trial studies the following conditions: Implant Based Breast Reconstruction, Tissue Expansion.
What interventions are being tested in trial NCT05975372?
The interventions under investigation include: Blossom tissue expander (DEVICE), Standard tissue expansion (DEVICE).
Who is sponsoring clinical trial NCT05975372?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05975372 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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