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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01054794
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 or older
* Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
* Sufficiently symptomatic at time of proposed study (Minimum total baseline GCSI score of 1.5 or higher)
* Delayed gastric emptying (\>10% retention at 4 hours) on standard scintigraphic emptying study with patients off narcotics for at least 48 hours. Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
* Medically fit to undergo endoscopy
* Able and willing to remain in Calgary for the duration of the study (baseline period excepted)
* Able to provide written informed consent
Exclusion Criteria:
* Clinical evidence (including physical exam and/or EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Current use of anticoagulants, ASA, NSAIDS, clopidogrel, etc. which cannot safely be stopped for up to 5 days prior to the procedure in the opinion of the investigators
* Bleeding diathesis
* Severe immunocompromise
* Physical, mental, or compliance issues which in the opinion of the investigators may prevent the patient from completing the study
* Pregnant or breastfeeding females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01054794
Study Brief:
Protocol Section:
NCT01054794