NCT03657069

Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.

Detailed description

PRIMARY OBJECTIVES: I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction. SECONDARY OBJECTIVES: I. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications. OUTLINE: After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant. After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months

Conditions

• Breast Carcinoma
• Breast Disorder

Interventions

Type	Name	Description
DEVICE	Blossom	Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
OTHER	Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire	Ancillary studies

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-08-19
• Completion: 2020-08-19
• First posted: 2018-09-04
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study