Blossom Smart Expander for two-stage implant breast reconstruction or augmentation
Official title: Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Run by Stanford University · NCT05975372 · Data updated 2026-11-12
This study will test whether the Blossom Smart Expander, which slowly and continuously delivers small amounts of saline, can replace regular needle fills for women having two-stage implant-based breast reconstruction or augmentation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | November 17, 2023 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT05975372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 to 65 pursuing non-oncologic two-stage tissue expander/implant breast reconstruction or augmentation who can read and sign English consent are eligible.
✕Probably not a fit
Patients with active breast cancer, recent steroid use, major medical comorbidities (ASA III or greater), connective tissue disorders, those who are pregnant or nursing, over age 65, or unable to consent in English are excluded and would not be expected to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized 1:1 comparison of Blossom Smart Expander Technology versus standard percutaneous saline fills in women undergoing two-stage tissue expander/implant breast reconstruction or augmentation. The intervention pairs a Mentor Spectrum adjustable saline expander with the Blossom Syringe Assist to provide slow continuous infusion, while the control group receives conventional in-office needle fills. Patients are followed within one week of surgery and then weekly during expansion with clinical data collection until expansion is complete and drains are removed, followed by routine monthly follow-up as needed. Enrollment and surgeries occur at Stanford Hospital and Clinics with randomization at the time of expander placement.
Why it matters
Potential benefit: If successful, the device could reduce or eliminate repeated needle fills, decreasing patient discomfort and clinic visits while allowing more individualized expansion.
How similar studies have gone: Continuous-expansion devices like Blossom are commercially available and small studies and real-world use suggest reduced office fills and improved comfort, but randomized comparative evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruction will be approached for potential enrollment in the study. Exclusion Criteria: * Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.
Where it's running
-
Stanford Hospital and Clinics
Palo Alto, California, United States Recruiting
Study contacts
- Study coordinator: Dung H Nguyen, MD, PharmD
- Email: nguyendh@stanford.edu
- Phone: (650) 725-2766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.