CompletedNot Applicable

Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

Mexico82 participantsStarted 2017-04-01

Plain-language summary

Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising results in these patients. The investigators aims are to evaluate security and efficacy of this endoscopic treatment in participants with refractory gastroparesis.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with refractory gastroparesis based on delayed gastric emptying symptoms: Nausea, retching, vomiting, abdominal pain, early satiety, post-prandial fullness, bloating. * Refractoriness defines as the presence of symptoms with failure or recurrence after other type of treatment. * Any etiology: diabetes, post-surgical, idiopathic Exclusion Criteria: * Pregnancy * Portal hypertension * Gastric malignant condition * Active prepyloric ulcer * Mechanical pyloric stenosis

What they're measuring

Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs

Timeframe: 1, 6 and 12 months

Trial details

NCT IDNCT03126513

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-04-01

View on ClinicalTrials.gov More Gastroparesis Postoperative trials