By InvitationPhase 4

Botox or Botox With Esophageal Dilation in Patients With Achalasia

United States50 participantsStarted 2019-05-13

Plain-language summary

Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

dysphagia score

Timeframe: 12 months

Trial details

NCT IDNCT03654066

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Achalasia trials