At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 78 enrolled
Drug / intervention
MatriStem PSMdevice
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 Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
In Brief
A Phase 2 clinical trial evaluating MatriStem PSM for Esophageal Adenocarcinoma. Completed, enrolled 78 participants across 4 sites.
Detailed Summary
The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Adenocarcinoma
CountriesUnited States
CollaboratorsIntegra LifeSciences Corporation
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionFeb 2023
TodayJul 2026
First PostedOct 28, 2013
Enrollment StartOct 18, 2013
Primary CompletionFeb 24, 2023
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 12.7 years ago
Interventions
MatriStem PSMdevice
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.