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Tissue Expander

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

Study Summary

This trial is testing a new technology that may help breast reconstruction patients by slowly and continuously injecting small amounts of saline into breast expanders.

Eligible Conditions
  • Breast Cancer
  • Breast Disorder

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,339 Total Patients Enrolled
61 Trials studying Breast Cancer
111,180 Patients Enrolled for Breast Cancer
Dung NguyenPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Dung Nguyen 2018. "Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03657069.
~2 spots leftby Apr 2025
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