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The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia (POEM)

Primary Purpose

Achalasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Less invasive treatment for Achalasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.

Exclusion Criteria:

Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
The patient is at least one year postmenopausal (no menses for 12 months).
The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
Vulnerable populations, such as those with diminished mental acuity, will be excluded.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peroral Endoscopic Myotomy (POEM)

Arm Description

Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.

Secondary Outcome Measures

Eckardt symptom score

By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.

Full Information

NCT ID

NCT01584635

First Posted

January 12, 2012

Last Updated

October 27, 2016

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01584635

Brief Title

The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

Acronym

POEM

Official Title

Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed. The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achalasia

Keywords

Less invasive treatment for Achalasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peroral Endoscopic Myotomy (POEM)

Arm Type

Experimental

Arm Description

Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia

Intervention Type

Procedure

Intervention Name(s)

Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

Other Intervention Name(s)

Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy, Disease of the muscle of the esophagus., Disorder of the swallowing tube., Esophageal Motility Disorders, Esophageal Achalasia

Intervention Description

In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Time Frame

5 years post surgery

Secondary Outcome Measure Information:

Title

Eckardt symptom score

Description

By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry. Exclusion Criteria: Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol. Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met: The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation) The patient is at least one year postmenopausal (no menses for 12 months). The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration. Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods. Vulnerable populations, such as those with diminished mental acuity, will be excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Katzka, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

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