Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction

NAUnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2023

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions
Tissue ExpansionImplant Based Breast Reconstruction
Interventions
DEVICE

Blossom tissue expander

Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.

DEVICE

Standard tissue expansion

Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.

Trial Locations (1)

94304

Stanford Hospital and Clinics, Palo Alto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Marz Medical, Inc.

UNKNOWN

lead

Stanford University

OTHER