Blossom Smart Expander for two-stage implant breast reconstruction or augmentation
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05975372 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.