Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06575192 | Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants | PHASE3 | RECRUITING | 264 | — | — | Nov 5, 2024 | Feb 1, 2031 | Jun 1, 2026 | 22 | United States |
Number of participants with at least one major complication related to breast reconstruction.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Acellular Dermal Matrix | EXPERIMENTAL | Breast reconstruction with ARTIA Tissue Matrix. |
| Name | Type | Description |
|---|---|---|
| ARTIA Reconstructive Tissue Matrix | DEVICE | Surgical Implant |
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...