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

NCT ID NCT03654066

ENROLLING_BY_INVITATION Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 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.

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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

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