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Could a tiny cap on a colonoscope catch more hidden polyps?

NCT ID NCT07261319

Knowledge-focused Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding a transparent cap to the tip of a colonoscope helps doctors find more polyps (adenomas) in the lower part of the colon during a second look. About 614 adults aged 45 to 75 will be randomly assigned to get either a standard second exam or one with the cap. The goal is to see if the cap improves detection rates and reduces missed polyps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transparent cap device
What this could lead to
If successful, this simple cap could become a standard tool to improve polyp detection during colonoscopy, potentially reducing colorectal cancer risk.
What could go wrong
This is a small, early-stage study at one center. The cap may not significantly improve detection, and results may not apply to other settings or populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 614 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Ages

45 to 75 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 45-75 years Exclusion Criteria: * Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps * Patients with highly suspected or pathologically confirmed colorectal cancer * Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination) * Pregnant or breastfeeding women * Patients with gastrointestinal obstruction * Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome * Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders * Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days * Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum * A Boston Bowel Preparation Scale (BBPS) score \< 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing) * Use of non-guideline-recommended bowel preparation agents * Patients undergoing emergency colonoscopy * Inadequate withdrawal time (defined as a withdrawal time \<6 minutes during the first examination or \<2 minutes during the second examination)

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Conditions

The condition(s) this trial relates to.

colorectal adenoma

As listed by the trial registrant

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

Colorectal adenoma

How to take part

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

  1. The places running it

    1 site. 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

  • Huadong hospital, Fudan university

    Shanghai, Shanghai Municipality, 200040, China

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