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Short Vs Standard Length Myotomy in Achalasia

NCT04798547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-15

No results posted yet for this study

Summary

The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.

Conditions

  • Achalasia

Interventions

PROCEDURE

Short Myotomy

Evaluation of short length myotomy

PROCEDURE

Standard Length Myotomy

Standard Length Myotomy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04798547 on ClinicalTrials.gov