Status:
RECRUITING
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Marz Medical, Inc.
Conditions:
Tissue Expansion
Implant Based Breast Reconstruction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using ...
Detailed Description
All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will be given the optio...
Eligibility Criteria
Inclusion
- Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruction will be approached for potential enrollment in the study.
Exclusion
- Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05975372
Start Date
November 17 2023
End Date
July 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304