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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT00432835
Eligibility Criteria:
Inclusion Criteria:
* Sex: Male of Female
* Age Range: 18 to 70 inclusive
* Patients with GP of diabetic, surgically related or idiopathic etiology.
* Symptoms of GP for \>/= 1 year.
* Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
* Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values.
* The patient is willing and able to provide informed consent.
* The patient is willing and able to return for required follow-up visits.
Exclusion Criteria:
* Patients \< 18 or \>70 years in age.
* Patients with an active infection of any kind.
* Patients who the investigator determines are not candidates for endoscopic procedures.
* Women who are pregnant
* Inability or unwillingness to provide informed consent
* Unwilling or unable to return for required follow-up visits and examinations.
* Patients who are currently enrolled in another investigation of a medical device or drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00432835
Study Brief:
Protocol Section:
NCT00432835