Peroral Endoscopic Myotomy (POEM) for the Treatment of Ac... | NCT02073578

Studies
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

NCT02073578

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Sep 27, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Achalasia

Interventions

Peroral Endoscopic Myotomy (POEM)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2021

Last Update Posted Date

Sep 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Detailed Description

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Other	Peroral Endoscopic Myotomy (POEM)	Procedure: Peroral Endoscopic Myotomy (POEM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peroral Endoscopic Myotomy (POEM)	Procedure	Endoscopy myotomy for treatment of achalasia	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Efficacy of POEM Procedure	To assess adverse events related to POEM	Intraoperative to one year follow-up
Long-term patient-reported quality of life	To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.	Baseline to one year follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Achalasia
Age 16-80
ASA Class 1-3

Exclusion Criteria:

Pregnancy
Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

Patients who are taking immunosuppressive medications or are immunocompromised
Patients on anticoagulant medications or abnormal coagulation tests
Patients with severe medical comorbidities, in the judgment of the treating surgeon

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyle M Perry, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Wexner Medical Center		Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D004931	Esophageal Achalasia

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided