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Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

NCT06575192 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 783

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

ARTIA Reconstructive Tissue Matrix

Surgical Implant

OTHER

No Intervention

No ADM

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575192 on ClinicalTrials.gov