Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARTIA Reconstructive Tissue Matrix.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy
Overview
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
- Device ARTIA Reconstructive Tissue Matrix
Surgical Implant
Primary outcome measures
- Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 [Time frame: Month 18]
- Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately 36 Months]
Secondary outcome measures (3)
- Occurrence of Reconstructive Failure Per Breast After Stage 1 [Time frame: Month 18]
- Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2 [Time frame: Up to Month 18]
- Occurrence of Capsular Contracture per Breast [Time frame: Month 36]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Cedars-Sinai Medical Center /ID# 268326 — Los Angeles
- University Of California Irvine Medical Center /ID# 267428 — Orange
- Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196 — Palo Alto
- South Bay Plastic Surgeons /ID# 264192 — Torrance
- University Of Colorado - Anschutz Medical Campus /ID# 268627 — Aurora
- Private Practice - Dr. Wayne Lee /ID# 281661 — Brandon
- University of Florida College of Medicine /ID# 267485 — Gainesville
- Rush University Medical Center /ID# 275935 — Chicago
- … and 15 more centers
Identifiers
NCT: NCT06575192 · M24-708