Trial Investigating Efficacy of G-POEM (NCT05830994) | Clinical Trial Compass
UnknownNot Applicable
Trial Investigating Efficacy of G-POEM
Denmark20 participantsStarted 2023-04-12
Plain-language summary
The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* The ability to give signed written informed consent,
* Patients with diabetes and gastroparesis,
* Age \>18 years,
* Gastroparesis is diagnosed with technetium-scintigraphy,
* Normal gastroscopy,
Exclusion Criteria:
* Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator,
* Recent gastrointestinal surgery,
* Active duodenal/gastric ulcer disease,
* Diseases in the ventricle or previously complicated upper abdominal surgery,
* Previous bariatric surgery,
* Pregnancy or breastfeeding,
* Parkinson disease,
* Persons who, in the judgement of the investigator, may be unable to follow the protocol, Use of metoclopramide, domperidone, prucalopride, ghrelin, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin) during study period.
* drugs with an anti-cholinergic mechanism,
* Use of motility slowing agents: anticholinergic agents, calcium channel blockers, TCA, GLP-1 analogs, Lithium, diphenhydramin, glucagon, dopamine agonists, progesterone, L-dopa, calcitonine, octreotide, interferon alfa, sucralsulfate,
* botulinum toxin injections (eg, Botox®) by pyloric injection less than 4 months prior to procedure