Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
ConditionGastroparesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University
About this trial
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years of age
Referral for endoscopic treatment of Gastroparesis for symptom management
Disqualifiers
< 18 years of age
Absence of gastroparesis based on scintigraphy studies
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM
The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is. Nausea or Vomiting (score 0-5 for each of the following 3 criteria) * Nausea * Retching * Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria) * Stomach Fullness * Not able to finish a normal-sized meal * Feeling excessively full after meals * Loss of appetite Bloating (score 0-5 for each of the following 2 criteria) * Bloating * Stomach visibly larger
Time frame
60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months2
Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM
Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
Time frame
60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months3
Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM
Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health
Time frame
baseline and assess change at 1,3,6,12,24,36,48 & 60 months4
Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM
we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours
Time frame
baseline; and assess change at 6, and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov