Melodi Matrix™ in Breast Reconstruction
Recruiting
N/A
Interventional Study
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 702 (estimated)
- Sponsor
- Melodi Health, Inc. · Industry
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About This Trial
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Trial Locations
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Eligibility Criteria
Inclusion 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 …
Contacts