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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AbbVie
Study ID
NCT06575192
Phase
PHASE3
Status
Recruiting
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Conditions

  • Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARTIA Reconstructive Tissue Matrix — DEVICE
    Surgical Implant

Study Details

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.

Key Dates

Start date
Nov 5, 2024
Status verified
May 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
264 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acellular Dermal Matrix
    Breast reconstruction with ARTIA Tissue Matrix.

Primary Outcome Measure

Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1 [ Time Frame: Month 18 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center /ID# 268326Los AngelesCalifornia90048-
University Of California Irvine Medical Center /ID# 267428OrangeCalifornia92868-
Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196Palo AltoCalifornia94304-
South Bay Plastic Surgeons /ID# 264192TorranceCalifornia90505-
University Of Colorado - Anschutz Medical Campus /ID# 268627AuroraColorado80045-
Private Practice - Dr. Wayne Lee /ID# 281661BrandonFlorida33511-
University of Florida College of Medicine /ID# 267485GainesvilleFlorida32610-
Rush University Medical Center /ID# 275935ChicagoIllinois60612-3841-
Endeavor Health - Health Center & Immediate Care - Northbrook /ID# 266302NorthbrookIllinois60062-
Johns Hopkins Hospital /ID# 265917BaltimoreMaryland21287-
Washington University /ID# 264029St LouisMissouri63110-
University of Nevada - Main Campus /ID# 264017Las VegasNevada89154-
Rutgers New Jersey Medical School - Newark /ID# 264187NewarkNew Jersey07103-
Northwell Health Clinical Trials Office /ID# 268076Lake SuccessNew York11042-
NYU Langone Medical Center /ID# 265621New YorkNew York10016-6402-
Atrium Health Wake Forest Baptist Medical Center /ID# 264382Winston-SalemNorth Carolina27157-
Ohio State Havener Eye Institute - Columbus /ID# 266253ColumbusOhio43212-
Erlanger Health System /ID# 266608ChattanoogaTennessee37403-
East Tennessee State University /ID# 264321Johnson CityTennessee37614-
The University of Texas MD Anderson Cancer Center /ID# 264020HoustonTexas77030-
University of Virginia /ID# 265098CharlottesvilleVirginia22903-
AG Aesthetic Center /ID# 264233VancouverWashington98660-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity Of California Irvine Medical Center· Orange, CAStanford University Medical Center CTRU - 800 Welch Road· Palo Alto, CASouth Bay Plastic Surgeons· Torrance, CAUniversity Of Colorado - Anschutz Medical Campus· Aurora, COPrivate Practice - Dr. Wayne Lee· Brandon, FL

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