Evaluation of a Novel Endoscopic Treatment for Achalasia

Not Applicable

Completed

• Conditions: Achalasia
• Interventions: Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)

• Registration Number: NCT01770249
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POEM procedure	Per-oral Endoscopic Esophagomyotomy (POEM)	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States