At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
In Brief
A clinical study evaluating Blossom and Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire for Breast Carcinoma and Breast Disorder. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
Ancillary studies