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Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

NCT00619762 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2016-11-08

Study results available
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Summary

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

Conditions

Interventions

DEVICE

LTM - a porcine-based surgical mesh

Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Michael Franz, MD · LifeCell

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00619762 on ClinicalTrials.gov