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

Sponsor

AdventHealth (Other)

Overall Status

Recruiting

CT.gov ID

NCT05905016

Collaborator

(none)

600

Enrollment

Location

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Achalasia Esophageal Spasm, Diffuse Gastroparesis Swallowing Disorder Zenker Diverticulum

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Esophageal POEM Data will be collected for patients under going standard of care Esophageal POEM (E-POEM)
Gastric POEM Data will be collected for patients under going standard of care Gastric POEM (G-POEM)
Zenker's POEM Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older.
Scheduled to undergo POEM

Exclusion Criteria:

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