Evaluation of a Novel Endoscopic Treatment for Achalasia

University Hospitals Cleveland Medical Center10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Achalasia

Interventions

Per-oral Endoscopic Esophagomyotomy (POEM)PROCEDURE

The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Within the first 3 months after surgery

Data from ClinicalTrials.gov

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