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

NCT05975372 | Recruiting DMC FDA Device

• 1 other identifier: 67363
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Tissue Expansion; Implant Based Breast Reconstruction

Keywords

Implant based breast reconstruction; Tissue expansion

Outcome Measures

Primary Outcomes (2)

• Time until completion of tissue expansion

  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.

  Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.

• Incidence of complications

  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.

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

Secondary Outcomes (3)

• Patient satisfaction (BreastQ)

  Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).

• Patient satisfaction (device specific survey)

  Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).

• Pain associated with tissue expansion

  Patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).

Study Arms (2)

Blossom tissue expander

EXPERIMENTAL

The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be automatic via the Blossom device until appropriate volume is achieved. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.

Device: Blossom tissue expander

Standard tissue expansion

ACTIVE COMPARATOR

The standard tissue expansion group will undergo the same procedure with placement of the Mentor Spectrum tissue expander inserted above the pectoralis major muscle in the usual fashion. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be achieved via serial injections of sterile saline into the tissue expander during postoperative follow up visits. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.

Device: Standard tissue expansion

Interventions

Blossom tissue expander DEVICE

Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.

Also known as: Blossom smart expander device, Marz blossom syringe assist device, Blossom syringe assist device

Blossom tissue expander

Standard tissue expansion DEVICE

Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.

Standard tissue expansion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Marz Medical, Inc.: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

RECRUITING

Central Study Contacts

Dung H Nguyen, MD, PharmD

CONTACT

(650) 725-2766; nguyendh@stanford.edu

Elizabeth Tadevosyan, BS

CONTACT

818-269-1950; etadyan@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: By nature of the visible device, participants and care providers cannot be blinded to the treatments. Analysis of data generated during the trial will be blinded to the treatment groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants will be randomized to either undergo tissue expansion with the Blossom device (intervention group) or standard tissue expansion methods (control group).

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)