Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02073578
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Procedure: Peroral Endoscopic Myotomy (POEM)	N/A

Detailed Description

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Peroral Endoscopic Myotomy (POEM)	Procedure: Peroral Endoscopic Myotomy (POEM); Endoscopy myotomy for treatment of achalasia

Outcome Measures

Primary Outcome Measures

1. Safety and Efficacy of POEM Procedure [Intraoperative to one year follow-up]

   To assess adverse events related to POEM

2. Long-term patient-reported quality of life [Baseline to one year follow-up]

   To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of Achalasia

• Age 16-80

• ASA Class 1-3

Exclusion Criteria:

• Pregnancy

• Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

• Patients who are taking immunosuppressive medications or are immunocompromised

• Patients on anticoagulant medications or abnormal coagulation tests

• Patients with severe medical comorbidities, in the judgment of the treating surgeon

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Kyle M Perry, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyle A Perry, Assistant Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT02073578
• Other Study ID Numbers: 2011H0240
• First Posted: Feb 27, 2014
• Last Update Posted: Sep 27, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Kyle A Perry, Assistant Professor, Ohio State University: achalasia; POEM; peroral endoscopic myotomy; myotomy; Heller myotomy
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Sep 27, 2021