POEM: Evaluation of a Novel Endoscopic Treatment for Achalasia

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01770249
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 21
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
• Actual Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: POEM procedure An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach.

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.; Other Names: POEM

Outcome Measures

Primary Outcome Measures

1. 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 [Within the first 3 months after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Ponsky Jeffrey, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT01770249
• Other Study ID Numbers: 03-12-10
• First Posted: Jan 17, 2013
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by University Hospitals Cleveland Medical Center: dysphagia
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Apr 20, 2022