Peroral Endoscopic Myotomy for the Treatment of Achalasia | NCT04640753

Studies
Peroral Endoscopic Myotomy for the Treatment of Achalasia

NCT04640753

Sponsor

Methodist Health System

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Achalasia

Interventions

Endoscopic procedure for achalasia

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2019Actual

Primary Completion Date

Feb 5, 2027Estimated

Completion Date

Feb 5, 2027Estimated

First Submitted Date

Nov 27, 2019

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 23, 2020Actual

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

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 & a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021

Detailed Description

Subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic procedure and POEM and subsequent follow-up clinical visits as part of their standard medical care. All procedures, barring research activities such as consenting and data collection from Electronic Health Records, will be either clinically indicated and/or standard of care.

Each patient in the study will be assigned a Case ID number to de-identify their personal health information during data collection
The Case ID number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at MDMC.
A procedure report and outpatient clinical records for each subject's POEM procedure will be used to record each patient's data for the registry
That data will only be shared by members of the study (PIs, research coordinator) who require it for conducting of data collection/interpretation

"Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic procedure for achalasia	Procedure	POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease or no symptoms of chest pain	To continue and review our treatment outcomes, patient safety in cases with achalasia, we follow up after the procedure up to 180 days. Follow-up period varies from patient to patient.	upto 180 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
Above or equal to 18 years of age

Exclusion Criteria:

Any patient who has not undergone POEM for the treatment of Achalasia.
Below 18 years of age

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019. In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Crystee Cooper, DHEd	Contact	214-947-1280		clinicalresearch@mhd.com
Jennifer Kirchner	Contact	214-947-4459		ClinicalResearch@mhd.com

Overall Officials

Name	Affiliation	Role
Prashant Kedia, M.D.	The Methodist Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center	Recruiting	Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided