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Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
NCT05975372 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1,643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05975372 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05975372?
The interventions under investigation include: Blossom tissue expander (DEVICE), Standard tissue expansion (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05975372?
This trial is sponsored by Stanford University, which has 1,643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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