Clinical trial · Interventional
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial
NCT01823107CI-TRIAL-00040496completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Meso BioMatrix Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Meso BioMatrix Device
- description
- All subjects will have the Meso BioMatrix device implanted along with a tissue expander during the first stage of breast reconstruction. During the second stage of breast reconstruction, the tissue expander is replaced with a breast implant.
- interventionNames
- Device: Meso BioMatrix Device
Primary outcomes (1)
- measure
- Rate of Breast Related Adverse Events
- timeFrame
- 18 months
- description
- Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Non-smoker * Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction * Life expectancy greater than 18 months * Agreement to return for the trial required follow-up visits Exclusion Criteria: * Body mass index ≥ 35 * Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty * History of chronic corticosteroid use * Type I Diabetes * History of radiation therapy to the chest * Pre-operative treatment with induction chemotherapy for breast cancer * Pregnancy * Participating in another investigational drug or device trial that has not completed the follow-up period
References
Publications (1)
- DERIVEDSimpson AM, Higdon KK, Kilgo MS, Tepper DG, Alizadeh K, Glat PM, Agarwal JP. Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial. Plast Reconstr Surg. 2019 Jan;143(1):10e-21e. doi: 10.1097/PRS.0000000000005095. PMID 30589773