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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02798458
Eligibility Criteria:
Inclusion Criteria:
* Adults ages 18-70 years who have diagnosed Fabry disease either by enzyme testing in males or by enzyme and/or genetically confirmed mutation in females.
* Adults with Fabry disease having any gastrointestinal complaints within the past year.
* Endoscopic Mucosal Resection ONLY - Symptomatic subjects necessitating a sigmoidoscopy who are enzyme replacement therapy (ERT) naive OR less than 6 months of treatment.
Exclusion Criteria:
1. Fabry disease with other concomitant gastrointestinal diagnosis (Example:
Inflammatory Bowel Disease, Celiac Disease)
2. Pregnancy
3. Endoscopic mucosal resection exclusions:
1. Any contraindication to conscious sedation,
2. Contraindication to endoscopy,
3. Untreated or unmanageable coagulopathy,
4. Thrombocytopenia (\<50).
5. Patient on ERT for more than 6 months.
4. Exclusions for SmartPill:
1. Previous history of bezoars.
2. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication.
3. Any abdominal surgery within the past 3 months
4. History of diverticulitis, diverticular stricture, and other intestinal strictures
5. Tobacco use within eight hours prior to capsule ingestion and during the initial 8-hour recording on Day 0 or the Ingestion visit.
6. Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
7. BMI \> 38
8. Allergies to components of the SmartBar
9. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
10. Uncontrolled diabetes with a hemoglobin A1C greater than 10.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02798458
Study Brief:
Protocol Section:
NCT02798458