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Dye spray boosts Colonoscopy's hidden polyp detection

NCT ID NCT07601217

Diagnosis Sponsor: Changhai Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 spraying a mix of acetic acid and indigo carmine dye during colonoscopy helps doctors find more precancerous polyps (called sessile serrated lesions) in the right side of the colon compared to standard white-light colonoscopy. About 2,689 adults aged 45-85 getting a screening colonoscopy will take part. The goal is to see if this simple dye technique can catch polyps that are often missed, potentially preventing more colorectal cancers.

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 2,689 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 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.

Ages

45 to 85 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: * Patients whose age are between 45-85 * Patients who have indications for screening * Patients who have signed inform consent form. Exclusion Criteria: * Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps * Patients with a history of colonoscopy within the past 5 years * Patients with highly suspected or confirmed colorectal cancer * Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination * Pregnant or breastfeeding women * Patients with gastrointestinal obstruction * Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli * Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy * Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days * Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure) * Patients with an Aronchick bowel preparation score \>3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation * Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna * Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy * Patients with missing essential information in the case report form prior to enrollment

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Conditions

The condition(s) this trial relates to.

colon sessile serrated adenoma/polyp colorectal sessile serrated adenoma/polyp

As listed by the trial registrant

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

Sessile serrated lesion

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

  • China, Shanghai Changhai Hospital, Second Military Medical University

    Shanghai, Shanghai Municipality, 200433, China

More trials for these conditions

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