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Tissue Expander
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
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
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 moreAwards & 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
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,110 Total Patients Enrolled
61 Trials studying Breast Cancer
111,049 Patients Enrolled for Breast Cancer
Dung NguyenPrincipal InvestigatorStanford University
1 Previous Clinical Trials
15 Total Patients Enrolled