Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

NCT ID: NCT05905016

Last Updated: 2026-02-02

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

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2027-04-30

Brief Summary

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This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Detailed Description

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This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

This study will enroll 600 subjects over the next 4 to 5 years.

Conditions

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Achalasia Esophageal Spasm, Diffuse Gastroparesis Swallowing Disorder Zenker Diverticulum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Esophageal POEM

Data will be collected for patients under going standard of care Esophageal POEM (E-POEM)

No interventions assigned to this group

Gastric POEM

Data will be collected for patients under going standard of care Gastric POEM (G-POEM)

No interventions assigned to this group

Zenker's POEM

Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older.
2. Scheduled to undergo POEM

Exclusion Criteria

1. Any contraindication to performing endoscopy.
2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Yang, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth Orlando

Locations

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AdventHealth Orlando

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dennis Yang, MD

Role: CONTACT

407-303-2570

Facility Contacts

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Dennis Yang, MD

Role: primary

407-303-2570

Other Identifiers

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1798543

Identifier Type: -

Identifier Source: org_study_id

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