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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01631435
Eligibility Criteria:
Inclusion Criteria:
1. Subject ages 18-75 years, inclusive
2. Subject has known CD and signs and symptoms of active disease including one of the following:
* Chronic diarrhea
* Chronic abdominal pain
* Rectal bleeding
3. Subject has at least one of the following within three months of enrollment:
* Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin)
* Anemia (hemoglobin level below normal reference range)
* Hypoalbuminemia (albumin below normal reference range)
* Weight loss
4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.
5. Subject agrees to sign consent form
Exclusion Criteria:
1. Indeterminate Colitis
2. Ulcerative Colitis
3. Antibiotic Associated Colitis
4. Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
5. Other known infectious cause of increased symptoms
6. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
7. Definite long stricture seen on radiological exam.
8. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
9. Suspected GI stricture, followed by Pillcam Patency study or other imaging study that could not prove patency of the GI tract.
10. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
11. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
12. Subjects with known or suspected delayed gastric emptying
13. Subjects with known or suspected delayed Small bowel motility
14. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
15. Subject has Type I or Type II Diabetes.
16. Subject has any allergy or other known contraindication to the medications used in the study.
17. Subject has any condition, which precludes compliance with study and/or device instructions.
18. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
19. Concurrent participation in another clinical trial using any investigational drug or device.
20. Subject suffers from a life threatening condition.
21. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01631435
Study Brief:
Protocol Section:
NCT01631435