Breast ReconstructionADMIRENCT06456554
Acellular Dermal Matrix Investigation in Breast Reconstruction
A study testing Acellular Dermal Matrix (Cortiva Tissue Matrix) in people with Breast Reconstruction, run by RTI Surgical at 13 sites in United States.
Trial summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique. Read more about this study
- Who is it for?
- Ages 22 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 13 sitesUnited States
- Study dates
- 22 Nov 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Genetic female
- Age 22 or older at time of consent
- Undergoing immediate breast reconstruction
- 2 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Bonvallet, PhD contact
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Mamadou Seye, mamadou.seye@cuanschutz.edu
Christodoulos Kaoutzanis, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Bev Doyle, doyleb4@ccf.org
Risal Djohan, MD
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Shalini Shah
- Recruiting
MD Anderson
Houston, Texas, 77030
Sara Hull, 713-500-2000, SEHull@mdanderson.org
- Recruiting
University of Kansas
Lawrence, Kansas, 66045
Jessica Reynolds, 619-753-2866, jreynolds11@kumc.edu
- Recruiting
University of Arkansas
Little Rock, Arkansas, 72205
- Recruiting
NYU Langone Health
New York, New York, 10016
Brooke Miller, brooke.miller@nyulangone.org
Nolan Karp, MD
- Recruiting
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
Ken Watanabe, kw3145@cumc.columbia.edu
Camila Boneu, cb4123@cumc.columbia.edu
- Not yet recruiting
Mercy Hospital
Oklahoma City, Oklahoma, 73120
Maryann Martinovic, MD
- Recruiting
Mercy
Oklahoma City, Oklahoma, 73120
Maryann Martinovic, MD, (405) 749-7023, maryann.martinovic@mercy.net
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Robyn Broach, PhD, robyn.broach@pennmedicine.upenn.edu
Jessica Rose, DO
- Recruiting
Washington University
St Louis, Missouri, 63110
Aliyah Thomas, aliyaht@wustl.edu
Trina Ebersole, MD
- Recruiting
Mercy Hospital
St Louis, Missouri, 63141
Brenna Reilly, Brenna.Reilly@mercy.net
Michael Curtis, MD
About this study
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
- Conditions
- Breast Reconstruction
- Being tested
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal Matrix (Cortiva Tissue Matrix)Device
non-crosslinked dermis
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Breast reconstruction with Cortiva Tissue Matrix Receives: Device: Acellular Dermal Matrix (Cortiva Tissue Matrix) |
| no Acellular Dermal Matrix | No intervention | Breast reconstruction only with no ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major adverse events
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
Measured: 12 months
Health related quality of life
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Measured: 12 months
Secondary outcomes (4)
Change in quality of life
Change from baseline in quality of life as measured by the BREAST-Q
Measured: 1 year and 2 years
Procedure related adverse events
Rate of procedure-related adverse events requiring additional treatment
Measured: 3 months, 1 year and 2 years
Investigational device related adverse events
Rate of investigational device-related adverse events requiring additional treatment
Measured: 3 months, 1 year and 2 years
Histopathology assessment
Histopathology assessment at stage 2 procedure
Measured: stage 2 procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start22 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 467 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456554
- Sponsor's protocol ID
- RTI-CL-5000
- Acronym
- ADMIRE
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Dermal Matrix Investigation in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06456554
- Acronym / sponsor ID
- ADMIRE / RTI-CL-5000
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 467 participants (estimated)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)Breast reconstruction with Cortiva Tissue Matrix |
| no Acellular Dermal Matrix | No intervention | –Breast reconstruction only with no ADM |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Genetic female
- Age 22 or older at time of consent
- Undergoing immediate breast reconstruction
- 2 stage breast reconstruction using pre pectoral technique
- Nipple or skin sparing mastectomy
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Dermal Matrix (Cortiva Tissue Matrix)non-crosslinked dermis | Device | Acellular Dermal Matrix |
Primary outcome
Rate of major adverse events
Time frame: 12 months
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
Health related quality of life
Time frame: 12 months
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
4 secondary outcomes
Change in quality of life
Time frame: 1 year and 2 years
Procedure related adverse events
Time frame: 3 months, 1 year and 2 years
Investigational device related adverse events
Time frame: 3 months, 1 year and 2 years
Histopathology assessment
Time frame: stage 2 procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Bonvallet, PhD contact
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix (Cortiva Tissue Matrix) in people with Breast Reconstruction, run by RTI Surgical at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Villagomez (202-552-6013, avillagomez@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major adverse events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.