Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

Confocal technology, hailed as "optical biopsy," enables real-time cellular-level histological examination of mucosal surfaces. Its integration with double-balloon enteroscopy significantly enhances the clinical feasibility of targeted biopsy, early diagnosis, and endoscopic staging for small bowel diseases such as inflammatory bowel disease. Currently, confocal endoscopy is primarily applied to upper and lower gastrointestinal tract diseases, leaving small bowel pathologies largely unexplored. Consequently, establishing a diagnostic framework for small bowel tumors and non-neoplastic lesions using confocal enteroscopy, alongside developing quality assessment standards for its operational procedures, is of paramount importance.

NCT Number	NCT07363291
Lead Sponsor	Shanghai Jiao Tong University School of Medicine Collaborators: Shanghai Zhongshan Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Huashan Hospital, RenJi Hospital, Ruijin Hospital, Kashgar Second People's Hospital, Ningbo Hangzhou Bay Hospital
Conditions	Confocal Enteroscopy, Quality Assessment System, Standardized Implementation
Enrollment	600 participants
Start Date	2025-06-01
Primary Completion	2028-06-01 (estimated)
Study Completion	2028-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-23