Evaluating the use of endoscopic myotomy for gastrointestinal motility disorders
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
This study is testing how well a procedure called endoscopic myotomy works for people with different gastrointestinal motility disorders like achalasia and gastroparesis over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05905016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect prospective data on the clinical utility of peroral endoscopic myotomy (POEM) in patients with various gastrointestinal motility disorders. Participants will receive standard medical care while their outcomes will be recorded over a period of 4 to 5 years. The study will enroll 600 subjects, focusing on conditions such as achalasia, esophageal spasm, and gastroparesis. No experimental interventions will be performed, allowing for a clear assessment of POEM's effectiveness in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are scheduled to undergo peroral endoscopic myotomy.
Not a fit: Patients who have contraindications to performing endoscopy or are participating in other conflicting research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of POEM for treating gastrointestinal motility disorders, potentially improving patient outcomes.
How similar studies have performed: While this study is observational and focuses on standard care, similar approaches in evaluating endoscopic techniques have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Orlando, Florida
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Yang, MD — AdventHealth Orlando
- Study coordinator: Dennis Yang, MD
- Email: Dennis.Yang.MD@adventhealth.com
- Phone: 407-303-2570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.