NCT05975372

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will be given the option of study enrollment. Consenting patients will be enrolled and randomized 1:1 to undergo standard 2-staged breast reconstruction/ augmentation with conventional tissue expansion (control) or with application Blossom Smart Expander Technology (intervention) in the first stage reconstruction (tissue expansion). The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care. A Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom Syringe Assist device, will be 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. 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.

Conditions

• Tissue Expansion
• Implant Based Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	Blossom tissue expander	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.
DEVICE	Standard tissue expansion	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.

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-08-03
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study