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Could a gel help kids with narrow esophagi avoid repeated surgeries?

NCT ID NCT07560462

Disease control Sponsor: Shaare Zedek Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a budesonide gel, taken orally twice a day for 12 weeks, can reduce the number of endoscopic balloon dilations needed for children with esophageal strictures. The trial will enroll 32 children under 12 who have a narrowing where their esophagus was surgically repaired. The goal is to see if the gel helps them swallow effectively without needing as many procedures.

What this could mean

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

Active substance
budesonide gel
What this could lead to
If it works, this could reduce the number of painful dilation procedures children need for esophageal strictures.
What could go wrong
This is a small, early-stage trial with only 32 children. The treatment may not work better than standard care, and side effects are possible.

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 32 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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

Up to 12 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: * Infants and children \< 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia / tracheoesophageal fistula * Dysphagia score ≥1 * Parental consent Exclusion Criteria: * Additional stricture/s besides anastomotic stricture eg. Congenital stricture * Complicated stricture - including length \>2cm, significant angulation or irregularity * Neurological impairment or other cause of expected limitation to oral intake * Previous anastomotic dilatations * Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak * Suspected or verified thoracic vascular anomaly affecting esophageal patency or function * Verified co-diagnosis of eosinophilic esophagitis * Any contraindication to EBD according to treating physician's planned treatment course

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Conditions

The condition(s) this trial relates to.

Esophageal Stenosis

As listed by the trial registrant

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

Esophageal stricture

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

  • Shaare Zedek Medical Centre

    Jerusalem, 91031, Israel

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