Acellular Dermal Matrix Investigation in Breast Reconstruction
ADMIRE
1 other identifier
interventional
467
1 country
13
Brief Summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 30, 2026
April 1, 2026
2 years
June 7, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of major adverse events
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
12 months
Health related quality of life
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
12 months
Secondary Outcomes (4)
Change in quality of life
1 year and 2 years
Procedure related adverse events
3 months, 1 year and 2 years
Investigational device related adverse events
3 months, 1 year and 2 years
Histopathology assessment
stage 2 procedure
Study Arms (2)
Acellular Dermal Matrix
EXPERIMENTALBreast reconstruction with Cortiva Tissue Matrix
no Acellular Dermal Matrix
NO INTERVENTIONBreast reconstruction only with no ADM
Interventions
Eligibility Criteria
You may qualify if:
- Genetic female
- Age 22 or older at time of consent
- Undergoing immediate breast reconstruction
- stage breast reconstruction using pre pectoral technique
- Nipple or skin sparing mastectomy
- Willing and capable of providing informed consent
- Able to comply with study requirements
You may not qualify if:
- Planned concurrent reconstruction with pedicled flaps or free tissue
- Pregnant or breast feeding
- Investigator has determined tissue is unsuitable for two-stage breast reconstruction
- History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
- Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
- Vulnerable subject populations
- Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
- Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
- Active abscess or infection in the intended reconstruction site
- Residual gross tumor at the intended reconstruction site
- Active use of any tobacco/nicotine products
- Has body mass index (BMI) \>35
- Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
- Is currently taking medications including systemic steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RTI Surgicallead
- MCRAcollaborator
Study Sites (13)
University of Arkansas
Little Rock, Arkansas, 72205, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Kansas
Lawrence, Kansas, 66045, United States
Washington University
St Louis, Missouri, 63110, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
NYU Langone Health
New York, New York, 10016, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Mercy Hospital
Oklahoma City, Oklahoma, 73120, United States
Mercy
Oklahoma City, Oklahoma, 73120, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MD Anderson
Houston, Texas, 77030, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 13, 2024
Study Start
November 22, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share