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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00885469
Eligibility Criteria:
Inclusion Criteria:
* Patient age is 18 years or older
* Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE
* Patient agrees and signs the Informed Consent Form
* Currently taking PPI for at least 28 days.
Exclusion Criteria:
* Patient has dysphagia
* Patient has known Zenker's Diverticulum
* Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction
* Patient has a cardiac pacemakers or other implanted electro medical devices
* Patient who has undergone an EGD within past seven days
* Female patient is pregnant and/or lactating
* Patient is expected to undergo Magnetic Resonance Imaging (MRI) examination within 7 days after ingestion of the capsule
* Patient has had a prior pelvic or abdominal surgery of the gastrointestinal tract (other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator such as appendectomy or uncomplicated cholecystectomy)
* Patient has any condition which precludes compliance with the study and/or device instructions
* Patient suffers from life threatening conditions
* Patient is currently participating in another clinical study
* Patient is on medications that may coat the esophagus such as iron or sulcrafate.
* Contraindication for any radiation or barium (e.g., sensitivity or allergy) required to confirm excretion of the capsule if necessary.
* Patient is currently suffering from conditions like allergy, illness (flu) or anything else that causes congestion, excessive salivation, etc. that could foster difficulty in swallowing the capsule or affect the clarity of the CE images.
* Contraindicated for use of laxatives, or surgery required to remove a capsule e.g., colonoscopy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00885469
Study Brief:
Protocol Section:
NCT00885469