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Could adding a balloon stretch to botox help achalasia patients swallow better?

NCT ID NCT03654066

Symptom relief Sponsor: Vanderbilt University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 4 times

Summary

This study looks at whether combining Botox injections with a balloon dilation of the esophagus works better than Botox alone for people with achalasia, a rare swallowing disorder. The trial enrolls 50 adults who are not healthy enough for more invasive treatments. Participants are randomly assigned to receive either Botox alone or Botox plus dilation, and their swallowing symptoms are tracked using a patient-reported score.

What this could mean

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

Active substance
Botulinum toxin type A (Botox)
What this could lead to
If it works, this could offer a better symptom-relief option for achalasia patients who are not candidates for surgery or balloon dilation.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply broadly. Adding dilation may not improve symptoms and could carry extra risks like perforation.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

9 people

The number who actually took part.

Started

May 2019

Finished

Aug 2026

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 years and older

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: * Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM * Patient undergoing routine care upper endoscopy for achalasia Exclusion Criteria: * Less than 18 years old * Previous surgery for reflux or peptic ulcer disease * Significant medical conditions possibly placing subjects at risk to undergo endoscopy

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Conditions

The condition(s) this trial relates to.

achalasia Esophageal Achalasia

As listed by the trial registrant

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

Achalasia

Contacts and locations

Locations

  • Vanderbilt University Medical Center Endoscopy Laboratory

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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