Blossom for Breast Cancer

N/A

Waitlist Available

Led By Dung Nguyen

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed weekly for up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new method for breast reconstruction in breast cancer patients who have had a mastectomy. The new technology gradually and automatically adds saline to breast implants, making the process quicker and less painful. This method aims to reduce the need for regular clinic visits and painful injections.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed weekly for up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed weekly for up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed weekly for up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved

Secondary study objectives

BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score

Number of Participants With Device Malfunction Associated With Tissue Expansion Process

Number of Participants With Major Complications Associated With Tissue Expansion Process

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (Blossom Smart Expander Technology)Experimental Treatment2 Interventions

After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blossom

2018

N/A

~20

Do I qualify?Apply below to find out