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

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AbbVie

Status and phase

Enrolling
Phase 3

Conditions

Breast Reconstruction

Treatments

Other: No Intervention
Device: ARTIA Reconstructive Tissue Matrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT06575192
M24-708

Details and patient eligibility

About

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.

Enrollment

783 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
  • Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

783 participants in 2 patient groups

Acellular Dermal Matrix
Experimental group
Description:
Breast reconstruction with ARTIA Tissue Matrix.
Treatment:
Device: ARTIA Reconstructive Tissue Matrix
Non-Acellular Dermal Matrix (ADM) Control Group
Other group
Description:
Breast reconstruction without ADM.
Treatment:
Other: No Intervention

Trial contacts and locations

12

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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