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

Not Applicable

Completed

• Conditions: Known Crohn Disease Subjects
• Interventions: Device: Capsule endoscopy and Ileocolonoscopy tests

• Registration Number: NCT01942720
• Lead Sponsor: Medtronic - MITG

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2017-04-30
• Last Update Submitted: 2017-04-30
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsule endoscopy	Capsule endoscopy and Ileocolonoscopy tests	-

Primary Outcome Measures

Name	Time	Method
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)	6 months changefrom Baseline	To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff

Secondary Outcome Measures

Name	Time	Method
Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes	Baseline	Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.; SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Evaluate the Entire SB CE Scores	6 months change from Baseline	Evaluate the entire SB CE Scores (Lewis \& CECDEIS) change as compared to the change at TI in CE Scores (Lewis \& CECDEIS).; Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum	6 months change from Baseline	Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
Adverse Events (AE)	6 months	To assess safety related to capsule retention and other adverse events

Trial Locations

Locations (15)

Shafran Gastroenterology Center; 🇺🇸 Winter Park, Florida, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Atlantic Health System Morristown Memorial Pediatric GE; 🇺🇸 Morristown, New Jersey, United States

Metropolitan Gastroenterology Group; 🇺🇸 Chevy Chase, Maryland, United States

Gastroenterology Associates of Tidewater; 🇺🇸 Chesapeake, Virginia, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Indiana Unveresity Hospital; 🇺🇸 Indianapolis, Indiana, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Digestive Health Center of Michigan; 🇺🇸 Michigan, Michigan, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Children's Center for Digestive Healthcare; 🇺🇸 Atlanta, Georgia, United States

Iowa Digestive Disease Center; 🇺🇸 Clive, Iowa, United States

Dr. Romeo, Dayton Gastroenterology; 🇺🇸 Dayton, Ohio, United States