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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03654066
Other study ID # 181420
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date May 13, 2019
Est. completion date June 2025

Study information

Verified date May 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum toxin type A
Botox injection in the LES
Device:
Endoscope balloon dilator
Distal esophageal dilation
Other:
Patient reported outcomes
Subjects will complete two patient reported outcome measures (Eckardt and MADS).
Diagnostic Test:
Barium esophagram
Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium

Locations

Country Name City State
United States Vanderbilt University Medical Center Endoscopy Laboratory Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary dysphagia score Dysphagia score as measured by patient reported outcomes will be used to compare the two groups. The scale runs from 0 (no symptoms) to 100 (severe symptoms). 12 months
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