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

NCT05905016 | Recruiting

• 1 other identifier: 1798543
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Post procedural Reflux Rate

  Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM

  12 months

• 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

• 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

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.

You may qualify if:

• Age 18 years or older.
• Scheduled to undergo POEM

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia; Esophageal Spasm, Diffuse; Gastroparesis; Deglutition Disorders; Zenker Diverticulum

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Pathological Conditions, Anatomical

Study Officials

• Dennis Yang, MD

  AdventHealth Orlando

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Yang, MD

CONTACT

407-303-2570; Dennis.Yang.MD@adventhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: June 15, 2023
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)