Evaluation of a Novel Endoscopic Treatment for Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770249
• Other study ID #: 03-12-10
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

Description:

This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
• Ability to undergo general anesthesia
• The subject is > 18 yrs.of age
• Ability to give informed consent

Exclusion Criteria:

• o Sigmoid achalasia
• Contraindicated for EGD
• Pregnancy

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Per-oral Endoscopic Esophagomyotomy (POEM)
The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure	Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.	Within the first 3 months after surgery