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Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction

NCT04938102 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-10-21

No results posted yet for this study

Summary

The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.

Conditions

  • Esophagogastric Junction Disorder

Interventions

DRUG

Botulinum Toxin Type A Injection [Botox]

Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Reza Hejazi, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-07-31
Completion
2024-10-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938102 on ClinicalTrials.gov