Botox or Botox With Esophageal Dilation in Patients With Achalasia

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE4

Enrollment: 9

Sponsor: Vanderbilt University Medical Center

Location: Vanderbilt University Medical Center Endoscopy Laboratory Nashville Tennessee

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.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03654066). StuddyBuddy aggregates publicly available trial information.