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

Stanford University · with Marz Medical, Inc. · NCT05975372

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
November 17, 2023
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Blossom tissue expander; Standard tissue expansion

Conditions: Tissue Expansion; Implant Based Breast Reconstruction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Stanford Hospital and Clinics

    Palo Alto, CA 94304

    Site contact: Dung H Nguyen, MD, PharmD · (650) 725-2766 · nguyendh@stanford.edu

Study contacts (from the official record)

  • Dung H Nguyen, MD, PharmD · (650) 725-2766 · nguyendh@stanford.edu
  • Elizabeth Tadevosyan, BS · 818-269-1950 · etadyan@stanford.edu
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Blossom® Smart Expander Device for Tissue Expander/Implant-Based… (NCT05975372) | Bored Studies