Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
467
non-crosslinked dermis
University of Arkansas
Little Rock, Arkansas, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
Rate of major adverse events
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
Time frame: 12 months
Health related quality of life
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Time frame: 12 months
Change in quality of life
Change from baseline in quality of life as measured by the BREAST-Q
Time frame: 1 year and 2 years
Procedure related adverse events
Rate of procedure-related adverse events requiring additional treatment
Time frame: 3 months, 1 year and 2 years
Investigational device related adverse events
Rate of investigational device-related adverse events requiring additional treatment
Time frame: 3 months, 1 year and 2 years
Histopathology assessment
Histopathology assessment at stage 2 procedure
Time frame: stage 2 procedure
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University of Colorado
Aurora, Colorado, United States
RECRUITINGUniversity of Kansas
Lawrence, Kansas, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGMercy Hospital
St Louis, Missouri, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGNew York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGMercy Hospital
Oklahoma City, Oklahoma, United States
NOT_YET_RECRUITING...and 3 more locations