Evaluation of a Novel Endoscopic Treatment for Achalasia

NCT01770249 | Completed DMC

• 1 other identifier: 03-12-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Achalasia

Keywords

dysphagia

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

POEM procedure

OTHER

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)

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.

Also known as: POEM

POEM procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• o Sigmoid achalasia
• Contraindicated for EGD
• Pregnancy

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ponsky Jeffrey, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

US (1)