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NCT Number: NCT05905016

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

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

Recruiting

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Esophageal Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Esophageal Spasm, Diffuse Gastroenteritis Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Stomach Diseases Swallowing Disorder Zenker Diverticulum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location status: Recruiting

Location contact

Dennis Yang, MD

CONTACT

[email protected]

407-303-2570

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Post procedural Reflux Rate

    Time frame: 12 months

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

  2. Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis

    Time frame: 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.

  3. Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence

    Time frame: 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.

  4. Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Yang, MD

CONTACT

[email protected]

407-303-2570

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Acronym: POEM

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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