Breast Reconstruction
Conditions
Keywords
Breast Reconstruction, ADORA, ARTIA
Brief summary
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.
Interventions
DEVICEARTIA Reconstructive Tissue Matrix
Surgical Implant
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 breast without planned mastectomy or residual gross local tumor of the breast after mastectomy. * Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 | Month 18 | Number of participants with at least one major complication related to breast reconstruction. |
| Number of Participants with Adverse Events (AEs) | Up to Approximately 36 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Reconstructive Failure Per Breast After Stage 1 | Month 18 | Number of participants with an occurrence of reconstructive failure per breast. |
| Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2 | Up to Month 18 | Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale. |
| Occurrence of Capsular Contracture per Breast | Month 36 | Number of participants with an occurrence of capsular contracture per breast. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed