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New treatment option for Breast Reconstruction
Official title Melodi Matrix™ in Breast Reconstruction
ClinicalTrials.gov ID: NCT06027996
What this study is testing
- What it's testing
- Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
- 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
You may be able to join if
- Female.
- Age 22 or older at the time of enrollment.
- Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral...
- Is able to and willing to comply with the study requirements and providing informed consent.
You likely can't join if
- Has prior history of neoadjuvant radiotherapy.
- Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
- Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
- Has a Body Mass Index (BMI) \ 40.
- Is pregnant or is nursing; or plans to become pregnant during the course of the study.
- Has any connective tissue/autoimmune disorder or rheumatoid disease.
See the full eligibility criteria
- Female.
- Age 22 or older at the time of enrollment.
- Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
- Is able to and willing to comply with the study requirements and providing informed consent.
- Has prior history of neoadjuvant radiotherapy.
- Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
- Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
- Has a Body Mass Index (BMI) \ 40.
- Is pregnant or is nursing; or plans to become pregnant during the course of the study.
- Has any connective tissue/autoimmune disorder or rheumatoid disease.
- Has known allergies to study device materials.
- Is participating in another treatment research study that may interfere with study endpoints.
- Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
- Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
- Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Staten Island, New York, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Rapid City, South Dakota, United States
- Houston, Texas, United States
- Salt Lake City, Utah, 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States; Staten Island, New York, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, 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.