Clinical trial NCT01942720: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
Official title: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Known Crohn Disease Subjects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
timeFrame: 6 months changefrom Baseline
Secondary outcomes:
measure: Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes
timeFrame: Baseline
measure: Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum
timeFrame: 6 months change from Baseline
measure: Evaluate the Entire SB CE Scores
timeFrame: 6 months change from Baseline
measure: Adverse Events (AE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Children's Center for Digestive Healthcare
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Unveresity Hospital
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Michigan
country: United States
facility: Digestive Health Center of Michigan
state: Michigan
city: Morristown
country: United States
facility: Atlantic Health System Morristown Memorial Pediatric GE
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Dayton
country: United States
facility: Dr. Romeo, Dayton Gastroenterology
state: Ohio
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: Jonathan Leighton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cyder Cinai LA
name: Gil Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melmed GY, Dubinsky MC, Rubin DT, Fleisher M, Pasha SF, Sakuraba A, Tiongco F, Shafran I, Fernandez-Urien I, Rosa B, Papageorgiou NP, Leighton JA. Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study. Gastrointest Endosc. 2018 Dec;88(6):947-955.e2. doi: 10.1016/j.gie.2018.07.035. Epub 2018 Aug 4.