NCT01584635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

January 12, 2012

Last Update Submit

October 27, 2016

Conditions

Achalasia

Keywords

Less invasive treatment for Achalasia

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years post surgery

Secondary Outcomes (1)

  • Eckardt symptom score

    5 years

Study Arms (1)

Peroral Endoscopic Myotomy (POEM)

EXPERIMENTAL

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

Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

Interventions

Peroral Endoscopic Myotomy a less invasive treatment for AchalasiaPROCEDURE

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

Also known as: Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy, Disease of the muscle of the esophagus., Disorder of the swallowing tube., Esophageal Motility Disorders, Esophageal Achalasia
Peroral Endoscopic Myotomy (POEM)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Officials

  • David Katzka, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2012

First Posted

April 25, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

US(1)