Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

NCT01823107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-09-10

Study results available
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Summary

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

Interventions

DEVICE

Meso BioMatrix Device

Sponsors & Collaborators

  • Kensey Nash Corporation

    lead INDUSTRY

Principal Investigators

  • Forde Hansell · DSM Biomedical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-06-30
Completion
2017-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT01823107 on ClinicalTrials.gov