Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Scheduled to undergo POEM
Disqualifiers
Any contraindication to performing endoscopy.
Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Trial population
Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 3 trial groupsGroup A: Esophageal POEM
Group B: Gastric POEM
Group C: Zenker's POEM
Trial outcomes
Primary outcomes
1
Post procedural Reflux Rate
Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM
Time frame
12 months2
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.
Time frame
12 months3
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.
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov