Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Medtronic

Status: Completed

Conditions: Known Crohn Disease Subjects

Treatments: Device: Capsule endoscopy and Ileocolonoscopy tests

Study type: Interventional

Funder types: Industry

Identifiers

NCT01942720

MA-209

Details and patient eligibility

About

This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Full description

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .

Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease

Enrollment: 74 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject ages 2-75 years, inclusive
2. Subjects with a diagnosis of known Crohn disease
3. Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
5. Subject or parent agrees to sign consent form

Exclusion criteria

The presence of any of the following will exclude a subject from study enrollment:

1. Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
3. Stricture seen on radiological exam.
4. Indeterminate Colitis
5. Ulcerative Colitis
6. Antibiotic Associated Colitis
7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, 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 is expected to undergo MRI examination within 7 days after ingestion of the capsule.
11. Subjects with known or suspected delayed gastric emptying
12. Subjects with known or suspected delayed Small bowel motility
13. Subject has any allergy or other known contraindication to the medications used in the study.
14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
15. Unwillingness to use a medically accepted method of contraception throughout duration of study
16. Concurrent participation in another clinical trial using any investigational drug or device.
17. Subject has cardiac pacemaker or other implanted electromedical devices
18. Subject suffers from a life threatening condition.
19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Capsule endoscopy

Other group

Treatment:

Device: Capsule endoscopy and Ileocolonoscopy tests