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:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT06783504
Eligibility Criteria:
Inclusion Criteria:
* Wiling to have one teaspoon (5 ml) of blood drawn.
* Diagnosed with gastroparesis for twelve months or longer
* Diagnosed with diabetes either Type 1 or Type 2
* Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.
* Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.
* Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.
* Documented Hb A1c within three months of screening or at the time of screening (\<=8.0)
Exclusion Criteria:
* Unable to provide consent
* Pregnant females
* Medical records indicate intestinal pseudo-obstruction
* Diagnosed with cardiac arrhythmia
* History of prior gastric surgery
* History of vagotomy
* History of organ transplantation
* History of seizures
* Diagnosed with primary swallowing disorders
* Subjects who are dependent on drugs like Marinol for their condition
* Those diagnosed with psychogenic vomiting and not related to gastroparesis
* Medically unstable subjects
* Those at high surgical risk
* Subjects taking narcotic analgesics daily.
* Those with poorly controlled diabetes mellitus (Hgb A1c\>8) within three months of screening or at the time of screening.
* Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded
* Those having a cardiac pacemaker will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06783504
Study Brief:
Protocol Section:
NCT06783504