A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
Megadott ok: Inability to recruit patients for Sham controlled study; therefore, the study was terminated
A legfontosabb adatok
- Hol
- Rochester és Scottsdale (Egyesült Államok)Mind a 2 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- Mayo Clinic - ArizonaScottsdale, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Mayo Clinic
- Azonosító
- NCT04869670
- A regiszteradat frissítve
- 2026. május 22.
- Eredeti leírás
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.A teljes eredeti leírásKevesebb
A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
Bevonási feltételek: Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration; Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit; Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone); Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying; No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
Kizáró feltételek: Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider; New medications for gastroparesis-related symptoms started within 1 month prior to registration; Botox injection into the pylorus within 3 months prior to registration; Another active disorder which could explain symptoms in the opinion of the investigator; Failure to give informed consent; Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study; Allergy to eggs or Egg Beaters and Ensure; Poorly controlled diabetes with HbA1c of greater than 10% at time of screening; Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater; Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours; Pregnancy or nursing.