At a glance
ClinicalIndex Comparison RecordN/ACompleted· 17 enrolled
Drug / intervention
LTM - a porcine-based surgical meshdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
In Brief
An observational study evaluating LTM - a porcine-based surgical mesh for Breast Cancer. Completed, enrolled 17 participants across 5 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedFeb 2008
Primary CompletionOct 2009
Study CompletionDec 2009
TodayJul 2026
First PostedFeb 21, 2008
Enrollment StartOct 1, 2007
Primary CompletionOct 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.4 years ago
Interventions
LTM - a porcine-based surgical meshdevice
Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy