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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT06529159
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be 18 years or older
2. Confirmed untreated H. pylori infection
3. Able to understand and sign informed consent
4. Available to return for all routine follow-up study visits
5. Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study.
Exclusion Criteria:
1. Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.
2. Pregnancy or puerperium
3. Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
4. Lactation
5. An inability to provide informed consent
6. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.
7. Hernias / aspiration risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06529159
Study Brief:
Protocol Section:
NCT06529159