Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT05830994
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05830994
Study Brief:
Protocol Section:
NCT05830994