NCT07363291 Standardized Implementation and Quality Assessment System for Confocal Enteroscopy
| NCT ID | NCT07363291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Confocal Enteroscopy |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-06-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07363291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Confocal Enteroscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07363291 currently recruiting?
Yes, NCT07363291 is actively recruiting participants. Contact the research team at lxb_1969@163.com for enrollment information.
Where is the NCT07363291 trial being conducted?
This trial is being conducted at Hefei, China, Ningbo, China, Kashgar, China, Shanghai, China and 4 additional locations.
Who is sponsoring the NCT07363291 clinical trial?
NCT07363291 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 600 participants.