Evaluation of a Novel Endoscopic Treatment for Achalasia

NCT ID: NCT01770249

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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

Conditions

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Achalasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Per-oral Endoscopic Esophagomyotomy (POEM)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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POEM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ponsky Jeffrey, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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03-12-10

Identifier Type: -

Identifier Source: org_study_id

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