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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: Recruiting NA study of Implant Based Breast Reconstruction and Tissue Expansion, sponsored by Stanford University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.
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 |
What NCT05975372 shows while recruiting
NCT05975372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Implant Based Breast Reconstruction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05975372's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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