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New treatment option for Breast Reconstruction
Official title Acellular Dermal Matrix Investigation in Breast Reconstruction
ClinicalTrials.gov ID: NCT06456554
What this study is testing
- What it's testing
- Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only. Healthy volunteers may be eligible.
You may be able to join 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
You likely 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...
- Vulnerable subject populations
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Aurora, Colorado, United States
- Lawrence, Kansas, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Duarte, California, United States; Aurora, Colorado, United States; Lawrence, Kansas, United States; St Louis, Missouri, United States; New York, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.