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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular Dermal Matrix | Experimental | Breast reconstruction with ARTIA Tissue Matrix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTIA Reconstructive Tissue Matrix | Device | Surgical Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 | Number of participants with at least one major complication related to breast reconstruction. | Month 18 |
| Number of Participants with Adverse Events (AEs) | 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. | Up to Approximately 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Reconstructive Failure Per Breast After Stage 1 | Number of participants with an occurrence of reconstructive failure per breast. | Month 18 |
| Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center /ID# 268326 | Recruiting | Los Angeles | California | 90048 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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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. |
| Up to Month 18 |
| Occurrence of Capsular Contracture per Breast | Number of participants with an occurrence of capsular contracture per breast. | Month 36 |
| University Of California Irvine Medical Center /ID# 267428 |
| Recruiting |
| Orange |
| California |
| 92868 |
| United States |
| Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 | Recruiting | Palo Alto | California | 94304 | United States |
| South Bay Plastic Surgeons /ID# 264192 | Completed | Torrance | California | 90505 | United States |
| University Of Colorado - Anschutz Medical Campus /ID# 268627 | Recruiting | Aurora | Colorado | 80045 | United States |
| Private Practice - Dr. Wayne Lee /ID# 281661 | Not yet recruiting | Brandon | Florida | 33511 | United States |
| University of Florida College of Medicine /ID# 267485 | Recruiting | Gainesville | Florida | 32610 | United States |
| Rush University Medical Center /ID# 275935 | Recruiting | Chicago | Illinois | 60612-3841 | United States |
| Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302 | Recruiting | Northbrook | Illinois | 60062 | United States |
| Johns Hopkins Hospital /ID# 265917 | Recruiting | Baltimore | Maryland | 21287 | United States |
| Washington University /ID# 264029 | Recruiting | St Louis | Missouri | 63110 | United States |
| University of Nevada - Main Campus /ID# 264017 | Recruiting | Las Vegas | Nevada | 89154 | United States |
| Rutgers New Jersey Medical School - Newark /ID# 264187 | Recruiting | Newark | New Jersey | 07103 | United States |
| Northwell Health Clinical Trials Office /ID# 268076 | Recruiting | Lake Success | New York | 11042 | United States |
| NYU Langone Medical Center /ID# 265621 | Completed | New York | New York | 10016-6402 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 264382 | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Ohio State Havener Eye Institute - Columbus /ID# 266253 | Recruiting | Columbus | Ohio | 43212 | United States |
| Erlanger Health System /ID# 266608 | Recruiting | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee State University /ID# 264321 | Recruiting | Johnson City | Tennessee | 37614 | United States |
| The University of Texas MD Anderson Cancer Center /ID# 264020 | Recruiting | Houston | Texas | 77030 | United States |
| University of Virginia /ID# 265098 | Completed | Charlottesville | Virginia | 22903 | United States |
| AG Aesthetic Center /ID# 264233 | Recruiting | Vancouver | Washington | 98660 | United States |