Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

NCT07363291 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Observational

Started

2025-06-01

Last updated

2026-01-23

Condition(s) studied

Confocal EnteroscopyQuality Assessment SystemStandardized Implementation

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Aged 18-70 years and scheduled to undergo small-bowel endoscopy. * Able to provide written informed consent and willing to participate in the study. * Certified gastroenterologists with an intermediate (or higher) professional title. Have completed formal training and passed competency assessments in gastroscopy, colonoscopy, and small-bowel endoscopy. -Willing to participate and able to provide written informed consent. Exclusion Criteria: * Poor general condition, severe hepatic or renal insufficiency, or inability to tolerate complete endoscopic examination. * Known hypersensitivity to any study-related agents (fluorescein sodium, polyethylene glycol, lidocaine mucilage). * Currently enrolled in another clinical trial. * Never perform endoscopic procedures. * Endoscopic procedure or image-reading volume \< 100 cases in the past 2 years. * Medical license revoked or currently suspended for any reason.

Primary outcome measure(s)

procedural success rate — 14 days
the proportion of examinations in which confocal enteroscopy was successfully completed

Trial sites (8)

Facility	City	Region	Status
Renji Hospital Anhui Hospital	Hefei	Anhui	Recruiting
Ningbo Hangzhou Bay Hospital	Ningbo	Zhejiang	Recruiting
Kashgar Second People's Hospital	Kashgar	China	Recruiting
Huashan Hospital, Fudan University	Shanghai	China	Recruiting
Renji Hospital	Shanghai	China	Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	China	Recruiting
Shanghai Sixth People's Hospital	Shanghai	China	Recruiting
Zhongshan Hospital, Fudan University	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363291 on ClinicalTrials.gov ↗ ← All trials in China