ARTIA Reconstructive Tissue Matrix for Breast Reconstruction

Recruiting at 15 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Uncontrolled diabetes, Compromised wound healing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

783 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called ARTIA Reconstructive Tissue Matrix, a type of surgical implant, for individuals undergoing breast reconstruction immediately after a mastectomy. The trial will evaluate the safety and effectiveness of ARTIA compared to the usual method, which does not use ARTIA. Individuals who have had or plan to have a mastectomy and are interested in this new approach to breast reconstruction might be suitable candidates. This study targets those open to a two-step process, involving staged implant placement. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ARTIA Reconstructive Tissue Matrix is safe for breast reconstruction?

Research has shown that ARTIA, a type of tissue support, is under study for its safety in breast reconstruction surgeries. This support strengthens soft tissue, particularly after breast removal surgeries. It is provided sterile and intended for single use during surgery.

Although specific data from earlier studies is unavailable, ARTIA is in the final stages of testing, indicating a reasonable level of safety in previous tests. Treatments reaching this stage have typically been tested on people before and are considered relatively safe.

While no specific side effects are listed, potential trial participants should discuss any concerns with their doctor. This ensures they understand the possible risks and benefits before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ARTIA for breast reconstruction because it introduces an innovative approach using an acellular dermal matrix (ADM). Unlike traditional methods that often rely on the patient’s own tissue or synthetic materials, ARTIA uses a specially processed dermal matrix derived from donor tissue. This matrix is designed to integrate seamlessly with the patient’s body, potentially reducing the risk of complications and improving the overall aesthetic outcome. By offering a more natural integration and reducing recovery time, ARTIA could represent a significant advancement over existing reconstruction options.

What evidence suggests that ARTIA is effective for breast reconstruction?

Research has shown that the ARTIA Reconstructive Tissue Matrix holds promise for breast reconstruction. In this trial, participants will be assigned to one of two groups: one group will undergo breast reconstruction with the ARTIA Tissue Matrix, while the other will have reconstruction without an Acellular Dermal Matrix (ADM). Studies have reported an implant loss rate of about 4.9% out of 500 procedures with ARTIA, comparable to other well-known materials used in these surgeries. ARTIA has demonstrated effectiveness equal to these established materials, supporting successful breast reconstruction after a mastectomy. Evidence suggests that ARTIA is a reliable choice for those undergoing immediate, two-stage, implant-based reconstruction. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults planning to have a mastectomy and immediate two-stage breast reconstruction. Participants must be willing to undergo the procedure using ARTIA, a reconstructive tissue matrix, or opt for no additional materials.

Inclusion Criteria

I am willing to have breast reconstruction with or without a specific technique immediately.

I am scheduled for a mastectomy on one or both breasts.

Exclusion Criteria

I have breast cancer and am not planning to have, or haven't had all the tumor removed by surgery.

I have a condition like uncontrolled diabetes that affects how my wounds heal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants undergo the first stage of implant-based breast reconstruction with or without ARTIA Tissue Matrix

Up to 18 months

Treatment Stage 2

Participants undergo the second stage of implant-based breast reconstruction

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of satisfaction and complications

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• ARTIA

Trial Overview The study tests the safety and effectiveness of ARTIA Reconstructive Tissue Matrix in breast reconstruction after mastectomy compared with traditional methods without this material.

How Is the Trial Designed?

Group I: Non-Acellular Dermal Matrix (ADM) Control Group Experimental Treatment 1 Intervention

Breast reconstruction without ADM.

Group II: Acellular Dermal Matrix Experimental Treatment 1 Intervention

Breast reconstruction with ARTIA Tissue Matrix.

ARTIA is already approved in United States for the following indications:

Approved in United States as ARTIA Reconstructive Tissue Matrix for:

• Soft tissue reinforcement in plastic and reconstructive surgery, including hernia repair and body wall defects

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study of 51 patients undergoing 83 Artia™-assisted breast reconstructions, the overall complication rate was low at 10.8%, with specific issues like seromas and implant losses being relatively rare.

The early outcomes of Artia™-assisted breast reconstruction are promising, showing complication rates comparable to established acellular dermal matrices, suggesting it is a safe option for patients undergoing breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant-based breast reconstruction with Artia™ tissue matrix. Fakim, B., Highton, L., Gandhi, A., et al.[2020]

A systematic review of 45 studies involving 5089 patients found that animal-derived acellular dermal matrices (ADMs), particularly Braxon®, are commonly used in prepectoral direct-to-implant breast reconstruction, with specific patient criteria such as a subcutaneous layer > 1 cm and no prior radiotherapy being important for successful outcomes.

The study identified increased complication risks in smokers, patients who had radiation treatment, those with larger breast volumes, and those requiring axillary dissection, while the effects of diabetes, high body mass index, and breast implant size on outcomes were inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate post-mastectomy prepectoral breast reconstruction with animal derived acellular dermal matrices: A systematic review. Tellarini, A., Garutti, L., Corno, M., et al.[2023]

In a study comparing 29 patients undergoing subpectoral breast reconstruction to 34 patients receiving prepectoral reconstruction with anterior implant coverage, both methods showed similar complication rates, indicating that the new technique is safe.

The prepectoral approach resulted in a shorter drain removal period and improved breast symmetry, suggesting it may offer functional and cosmetic advantages over traditional methods, although subjective satisfaction levels were similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prepectoral breast reconstruction with complete anterior implant coverage using a single, large, square-shaped acellular dermal matrix. Hong, HK., Kim, YH., Lee, JS., et al.[2022]

In a study of 59 patients undergoing direct-to-implant breast reconstruction with acellular dermal matrix, 35 patients (59%) experienced surgical complications, highlighting a significant risk associated with this technique.

Larger mastectomy weight was identified as a key predictor of complications, suggesting that DTI ADM-assisted reconstruction may be safer for patients with small to moderate breast sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial. Negenborn, VL., Dikmans, REG., Bouman, MB., et al.[2019]

Artia, a porcine acellular dermal matrix, shows promising biointegration and vascular ingrowth in a murine model of irradiated breast reconstruction, indicating its potential effectiveness for clinical use.

Despite some impact from radiation fibrosis, Artia maintained robust cellular and vascular integration, with increased oxygen saturation observed within 14 days, suggesting it could be beneficial for patients undergoing breast reconstruction after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Biointegration of a Porcine Acellular Dermal Matrix in a Novel Radiated Breast Reconstruction Model. Cottler, PS., Sun, N., Thuman, JM., et al.[2021]

In a study of 51 patients undergoing breast reconstruction with acellular dermal matrices (ADMs), the thickness of the ADM (thin vs. thick) did not significantly affect postoperative complication rates or the duration of drainage.

Patient satisfaction, measured using the BREAST-Q questionnaire, showed no significant differences between the two ADM thickness groups, suggesting that surgeons can choose ADM thickness based on personal preference without impacting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of human acellular dermal matrix thickness on complication rate and patient-reported outcomes in implant-based immediate breast reconstruction. Hong, SE., Kim, JH.[2022]

In a study of 84 breast reconstructions, the overall rate of prosthesis implant removal was 21.4%, with significantly higher rates of 52.17% in smokers compared to 9.84% in non-smokers, indicating that smoking is a major risk factor for reconstruction failure.

Patients who had undergone ipsilateral breast radiation therapy (IBRT) also faced increased risks of implant removal, particularly if the radiation was administered after immediate breast reconstruction, suggesting that both smoking and IBRT should be considered when evaluating candidates for this type of reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast reconstruction with silicone prosthesis and acellular dermal matrix of porcine origin: Retrospective study of 84 cases. Pouzet, L., Hotton, J., François, C., et al.[2022]

In a study of 117 patients with acellular dermal matrix (ADM) breast reconstructions, there was a lower rate of capsular contracture (13.6%) compared to submuscular reconstructions (21.2%), although this difference was not statistically significant.

Patients with ADM reconstructions reported higher satisfaction scores regarding their breast aesthetics compared to those with submuscular techniques, indicating a potential advantage of ADM in long-term aesthetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BROWSE: A multicentre comparison of nine year outcomes in acellular dermal matrix based and complete submuscular implant-based immediate breast reconstruction-aesthetics, capsular contracture and patient reported outcomes. Wilson, RL., Kirwan, CC., O'Donoghue, JM., et al.[2022]

In a study involving 38 patients, the use of acellular dermal matrix (ADM) in tissue expander/implant-based breast reconstruction improved overall aesthetic scores by an average of 12.1%, with significant enhancements in breast contour, implant placement, and inframammary fold definition.

The findings suggest that incorporating ADM not only leads to better aesthetic outcomes, which may justify its cost, but also indicates potential additional benefits, warranting further research for more definitive guidelines on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does acellular dermal matrix really improve aesthetic outcome in tissue expander/implant-based breast reconstruction? Ibrahim, AM., Koolen, PG., Ganor, O., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06575192

Study Details | NCT06575192 | Evaluation of the Safety ... The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-708

Evaluation of the Safety and Effectiveness of ARTIA ... The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31201107/

Implant-based breast reconstruction with Artia™ tissue matrix The results are promising and are comparable to our experience using established ADMs, with an implant loss rate of 4.9% across 500 ADM-assisted implant ...

4. gdmedical.nl gdmedical.nl/wp-content/uploads/2018/05/Artia_Brochure_NL-1.pdf

ARTIA™ RECONSTRUCTIVE TISSUE MATRIX specifically Outcome data in patients who had received Artia™-assisted breast reconstruction was compared to patients recipient of other ADMs such as Strattice™ or ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09969

Evaluation of the Safety and Effectiveness of ARTIA ... The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast ...

6. ce.mayo.edu ce.mayo.edu/sites/default/files/media/2024-08/Artia.pdf

ARTIA™ RTM The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single ...

7. artiatissuematrix.com artiatissuematrix.com/

ARTIA™ Tissue Matrix is intended for single patient, one time ... ARTIA™ Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ...