Recruiting

Endoscopic Myotomy

Sponsor:

AdventHealth

Code:

NCT05905016

Conditions

Achalasia

Esophageal Spasm, Diffuse

Gastroparesis

Swallowing Disorder

Zenker Diverticulum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05905016

Start date

Oct 1, 2021

Status verified date

Jan, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • Post procedural Reflux Rate [ Time Frame: 12 months ]
  • Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis [ Time Frame: 12 months ]
  • Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence [ Time Frame: 12 months ]
  • Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Dennis Yang, MD

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

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Dennis Yang, MD

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

More Information

Sponsor

AdventHealth

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-02-02.