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New quality system aims to sharpen 'Optical Biopsy' for Hard-to-Reach gut

NCT ID NCT07363291

Knowledge-focused Sponsor: Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a standardized quality system for confocal enteroscopy, a technique that lets doctors see cells in real time during a small bowel exam. Researchers will enroll 600 people aged 18-70 who need small bowel endoscopy, along with certified gastroenterologists. The goal is to improve diagnostic accuracy and reduce complications for conditions like inflammatory bowel disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* 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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cryptogenic multifocal ulcerous stenosing enteritis indeterminate colitis Peutz-Jeghers syndrome small bowel Crohn disease small intestine lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Confocal enteroscopy Quality assessment system Standardized implementation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, China

  • Kashgar Second People's Hospital

    RECRUITING

    Kashgar, China

  • Ningbo Hangzhou Bay Hospital

    RECRUITING

    Ningbo, Zhejiang, China

  • Renji Hospital

    RECRUITING

    Shanghai, China

  • Renji Hospital Anhui Hospital

    RECRUITING

    Hefei, Anhui, China

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.