Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository

M
Mohammad Al-Haddad, MD

Primary Investigator

J
Jessica MacLean

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
1 Location

Brief description of study

What is the purpose of this study?

The purpose of having a database is to collect data related to endoscopic procedures performed by Indiana University physicians specifically for the treatment of gastroparesis. This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient’s condition and disease process that may lead to improved standard of care and improved patient management

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients are referred to IUMC specifically for the G-POEM procedure. They are placed on the G.I. procedure schedule for the G-POEM procedure from which they will be identified.

Detailed description of study

What will happen during the study?

Standard of care post-procedure follow up calls will be made to assess the patient. Study procedures will be: We will ask the subject to complete a complete SF-36 Hhealth Ssurvey questionnaires, Patient Assessment of Gastrointestinal Disorders-Symptom Severity Indez (PAGI-SYM) and nutrtional assessment before their standard of care procedure (baseline). We will also call the subject starting on the 5th day after the procedure, and will call or email, based on the preference the subject selected, the subject at the 1, 3, 6, 12, 24, 36, 48, & 60th month marks. They will be asked to complete the study questionnaires and these calls will take no more than 30 minutes of the subject's time.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastroparesis
  • Age: 18 years or above
  • Gender: All

Inclusion criteria:

- 18 years of age and older. - Referral for endoscopic treatment of Gastroparesis for symptom management
 

Exclusion criteria:

-       Absence of gastroparesis based on scintigraphy studies

Updated on 09 Apr 2025. Study ID: 1708840627
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