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Sponge on a string and AI could revolutionize esophageal cancer screening

NCT ID NCT07206589

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will test whether a combination of an AI-powered risk tool, a simple 'sponge on a string' test, and nurse navigation can improve screening for Barrett's esophagus and esophageal cancer. Over 1,000 adults at higher risk will be enrolled. The goal is to see if these less invasive methods lead to more people getting screened and diagnosed earlier than current standard approaches.

What this could mean

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

Active substance
sponge-on-a-string test, AI risk tool, nurse navigation
What this could lead to
If successful, this could make screening for Barrett's esophagus and esophageal cancer simpler, cheaper, and more accessible, potentially catching the disease earlier.
What could go wrong
This is an early-stage study focused on feasibility and accuracy, not a treatment. The new tests may not be more effective than current methods, and some patients may find the sponge test uncomfortable.

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 1,010 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * SPECIFIC AIM 1A: Adult patients 18-85 years old * SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score \> 0.087, indicating a higher risk for BE/esophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1. * SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease \[GERD\]+ \> 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity \[body mass index (BMI) \> 30\], ever smoker, family history of BE/EAC) * SPECIFIC AIM 1B: A "low risk" BE risk tool score (\< 0.0897) Exclusion Criteria: * SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma * SPECIFIC AIM 1A: Prior endoscopy in the last 10 years * SPECIFIC AIM 1A: Patients who are unable to consent * SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia * SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia * SPECIFIC AIM 1A: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure * SPECIFIC AIM 1A: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure * SPECIFIC AIM 1A: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure * SPECIFIC AIM 1A: Patients with a history of known varices or cirrhosis * SPECIFIC AIM 1A: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma * SPECIFIC AIM 1A: Patients with congenital or acquired bleeding diatheses * SPECIFIC AIM 1A: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma * SPECIFIC AIM 1A: Patients with limited life expectancy (\< 2 years): per provider judgement * SPECIFIC AIM 1B: History of Barrett's esophagus or esophageal adenocarcinoma * SPECIFIC AIM 1B: Prior endoscopy in the last 10 years * SPECIFIC AIM 1B: Patients who are unable to consent * SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia * SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia * SPECIFIC AIM 1B: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure * SPECIFIC AIM 1B: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure * SPECIFIC AIM 1B: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure * SPECIFIC AIM 1B: Patients with a history of known varices or cirrhosis * SPECIFIC AIM 1B: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma * SPECIFIC AIM 1B: Patients with congenital or acquired bleeding diatheses * SPECIFIC AIM 1B: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma * SPECIFIC AIM 1B: Patients with limited life expectancy (\< 2 years): per provider judgement

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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