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

Recruiting

• Conditions: Esophageal Spasm, Diffuse; Swallowing Disorder; Zenker Diverticulum; Achalasia; Gastroparesis

• Registration Number: NCT05905016
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-10
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.
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.
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.

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States