Clinical trial NCT04434781: Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
Official title: Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Keywords: GPOEM
Gastric Per-Oral Endoscopic Myotomy
Myotomy
Gastroparesis
g-poem
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As long as patients fall under the inclusion criteria and do not fall under exclusions, every patient can be considered. Patient must be declared safe to undergo procedure on individual basis from an evaluation from head doctor on study.

Brief summary: Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.

Detailed description: Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.

Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.

G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Referral for endoscopic treatment of Gastroparesis for symptom management

Exclusion Criteria:

* \< 18 years of age
* Absence of gastroparesis based on scintigraphy studies

Primary outcomes:
measure: Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM
timeFrame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
measure: Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM
timeFrame: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
measure: Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM
timeFrame: baseline and assess change at 1,3,6,12,24,36,48 & 60 months
measure: Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM
timeFrame: baseline; and assess change at 6, and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Mohammad Al-Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References: