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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05905016

Acronym

POEM

Enrollment

600

Registered

2023-06-15

Start date

2021-10-01

Completion date

2027-04-01

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Esophageal Spasm, Diffuse, Gastroparesis, Swallowing Disorder, Zenker Diverticulum

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Post procedural Reflux Rate	12 months	Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM
Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis	12 months	The main outcome of the study is to evaluate the proportion of patients who have clinical response to GPOEM. Clinical response is measured by the validated symptom assessment tool (gastroparesis cardinal symptom index - GCSI). Patients with a decrease in GCSI by one or more point will be defined as having a clinical response.
Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence	12 months	The main outcome of this study is to evaluate rate of recurrence of symptoms after Z-POEM for Zenker's diverticulum. Recurrence is defined as a return of patient's symptoms (dysphagia, odynophagia) at the time of clinic follow-up.
Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.	12 months	The main outcome measure is to evaluate the long-term efficacy of POEM for esophageal motility disorders. Efficacy or clinical response is usually assessed using the Eckardt score. An Eckardt score of \< 3 is traditionally defined as treatment response following POEM.

Countries

United States

Contacts

CONTACTDennis Yang, MD

Dennis.Yang.MD@adventhealth.com407-303-2570

PRINCIPAL_INVESTIGATORDennis Yang, MD

AdventHealth Orlando

Outcome results