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Blossom® Smart Expander Device for Breast Reconstruction

This study is looking at a new way to expand breast tissue for reconstruction or augmentation. If you're having two-stage, implant-based breast reconstruction, you might be able to join. The study compares the standard method of tissue expansion, which involves weekly or biweekly saline injections, with a new device called the Blossom® Smart Expander. This device aims to expand breast tissue slowly and continuously without frequent injections. Researchers want to see how long it takes to complete tissue expansion with each method and track any complications until the expander is removed, which is expected around 6 months after the first surgery. This study is open to women aged 18 to 65 who are having non-cancer related breast reconstruction or augmentation.

Study design
This study is an interventional study with 20 participants. Participants will be randomly assigned to either receive the Blossom® Smart Expander or standard tissue expansion.
What's involved
You would have surgery to place the expander, followed by weekly follow-up appointments until expansion is complete and surgical scars stabilize. You will also have a second surgery to exchange the expander for a permanent implant.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for complications until the tissue expander device is removed during the second stage surgery, which is approximately 6 months after the first surgery.

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NCT05975372

Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction

Recruiting
NAAges 18–65InterventionalPrevention
Stanford University
~20 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Blossom tissue expanderStandard tissue expansion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time until completion of tissue expansion
Measured over Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
+1 more outcome measured

Conditions

Tissue Expansion
Implant Based Breast Reconstruction

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Augmentation MammoplastyMammoplasty

Where it's being run

1 sites across 1 states
California1

Who to contact

Dung H Nguyen, MD, PharmD
[email protected]
(650) 725-2766
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Time until completion of tissue expansionExpansion is expected to be completed between 3 and 6 months after the stage 1 surgery.

    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.

  • Incidence of complicationsMonitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)

    Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and/ or device malfunction, etc. will be monitored and recorded in each study arm.