NCT02396745 - TECR & ECM Placement for Esophageal High Grade Dysplasia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 25, 2016

Primary Completion Date

March 22, 2018

Study Completion Date

March 22, 2018

Conditions

Barrett EsophagusEsophagusHigh Grade Dysplasia

Interventions

DEVICE

Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))

"TECR will be performed to resect the entire length and area of BE lesion.~ECM PLACEMENT:~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."

Trial Locations (1)

15224

West Penn Allegheny Health System, Pittsburgh