POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders

Achalasia Clinical Trial

— POEM  

Official title:

POEM a Novel Endoscopic Treatment for Achalasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01512719
• Other study ID #: 040411-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2021

Study information

• Verified date: July 2020
• Source: Hadassah Medical Organization
• Contact: Yoav Mintz, MD
• Phone: 97226776404
• Email: ymintz[@]hadasaah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

• Perforation of LES during dilatation

• Pregnant women

• mentally ill patients

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• POEM
Per Oral Endoscopic Myotomy for achalasia

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Hadassah Medical Center	Jerusalem
Israel	Hadassah Medical Organization	Jerusalem
Israel	Hadassah Medical Organization Ein-Kerem campus	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of dysphagia		up to 6 months postoperatively