Evaluation of a Novel Endoscopic Treatment for Achalasia (POEM)

University Hospitals (UH)

Status: Completed

Conditions: Achalasia

Treatments: Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)

Study type: Interventional

Funder types: Other

Identifiers

NCT01770249

03-12-10

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

POEM procedure

Other group

Description:

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.

Treatment:

Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)