Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Recruiting
Phase 3
Interventional Study
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 264 (estimated)
- Sponsor
- AbbVie · Industry
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About This Trial
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
* Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.
Exclusion Criteria:
* Has an existing carcinoma of the breas…
Contacts