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

Gastroparesis Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905016
• Other study ID #: 1798543
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: AdventHealth
• Contact: Dennis Yang, MD
• Phone: 407-303-2570
• Email: Dennis.Yang.MD[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achalasia
• Deglutition Disorders
• Diverticulum
• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Gastroparesis
• Swallowing Disorder
• Zenker Diverticulum

Locations

Country	Name	City	State
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post procedural Reflux Rate	Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM	12 months
Primary	Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis	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.	12 months
Primary	Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence	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.	12 months
Primary	Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.	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.	12 months