Abstract:
Resorbable adhesion barrier devices for use in abdominal and/or pelvic surgery are high-risk implantable medical devices. There are some difficulties in their clinical research. This article summarizes and analyzes the common problems of resorbable adhesion barrier devices for use in abdominal and/or pelvic surgery clinical studies from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in the design of clinical studies and clinical research.