What this study is
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
What's being tested
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
Intervention · DEVICE
non-crosslinked dermis
Study details
- Sponsor
- RTI Surgical
- Conditions
- Breast Reconstruction
- Enrolling
- 467 people
- Starts
- 2024-11-22
- Est. completion
- 2027-12
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
13 openUniversity of Arkansas
Little Rock, Arkansas, United States
RecruitingCity of Hope National Medical Center
Duarte, California, United States
- Shalini Shah · Contact
RecruitingUniversity of Colorado
Aurora, Colorado, United States
- Mamadou Seye · Contactmamadou.seye@cuanschutz.edu
- Christodoulos Kaoutzanis, MD · Principal investigator
RecruitingUniversity of Kansas
Lawrence, Kansas, United States
- Jessica Reynolds · Contact619-753-2866jreynolds11@kumc.edu
RecruitingWashington University
St Louis, Missouri, United States
- Aliyah Thomas · Contactaliyaht@wustl.edu
- Trina Ebersole, MD · Principal investigator
RecruitingMercy Hospital
St Louis, Missouri, United States
- Brenna Reilly · ContactBrenna.Reilly@mercy.net
- Michael Curtis, MD · Principal investigator
RecruitingNYU Langone Health
New York, New York, United States
- Brooke Miller · Contactbrooke.miller@nyulangone.org
- Nolan Karp, MD · Principal investigator
RecruitingNew York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
- Ken Watanabe · Contactkw3145@cumc.columbia.edu
- Camila Boneu · Contactcb4123@cumc.columbia.edu
- Christine Rohde, MD · Principal investigator
RecruitingCleveland Clinic
Cleveland, Ohio, United States
- Bev Doyle · Contactdoyleb4@ccf.org
- Risal Djohan, MD · Principal investigator
RecruitingMercy Hospital
Oklahoma City, Oklahoma, United States
- Maryann Martinovic, MD · Contact
Not yet recruitingMercy
Oklahoma City, Oklahoma, United States
- Maryann Martinovic, MD · Contact(405) 749-7023maryann.martinovic@mercy.net
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Robyn Broach, PhD · Contactrobyn.broach@pennmedicine.upenn.edu
- Jessica Rose, DO · Principal investigator
Recruiting- Recruiting
Study team
Sponsor
RTI Surgical
Study ID RTI-CL-5000
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.