Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT07363291

Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-23

600

Participants Needed

8

Research Sites

156 weeks

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Shanghai Zhongshan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 performed endoscopic procedures.
  • Endoscopic procedure or image-reading volume less than 100 cases in the past 2 years.
  • Medical license revoked or currently suspended for any reason.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Renji Hospital Anhui Hospital

Hefei, Anhui, China

Actively Recruiting

2

Ningbo Hangzhou Bay Hospital

Ningbo, Zhejiang, China

Actively Recruiting

3

Kashgar Second People's Hospital

Kashgar, China

Actively Recruiting

4

Huashan Hospital, Fudan University

Shanghai, China

Actively Recruiting

5

Renji Hospital

Shanghai, China

Actively Recruiting

6

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

7

Shanghai Sixth People's Hospital

Shanghai, China

Actively Recruiting

8

Zhongshan Hospital, Fudan University

Shanghai, China

Actively Recruiting

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Research Team

X

Xiaobo Li, MD. PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Standardized Implementation and Quality Assessment System for Confocal Enteroscopy | DecenTrialz