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Prospective Collection of Outcome Data Post POEM-TIF Procedure

NCT04052581 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-07-28

No results posted yet for this study

Summary

Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.

Conditions

  • Achalasia
  • Gastroesophageal Reflux Disease

Interventions

PROCEDURE

POEM-TIF

Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session

Sponsors & Collaborators

Principal Investigators

  • Mouen Khashab · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2023-07-26
Completion
2023-07-26

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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 NCT04052581 on ClinicalTrials.gov