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

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

Study Overview

• Status: Completed
• Conditions: Known Crohn Disease Subjects
• Intervention / Treatment: Device: Capsule endoscopy and Ileocolonoscopy tests

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Mayo Clinic
  • California
    • Los Angeles, California, United States
      • Cedars Sinai Medical Center
  • Florida
    • Jacksonville, Florida, United States
      • Borland-Groover Clinic
    • Winter Park, Florida, United States
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States
      • Children's Center for Digestive Healthcare
  • Illinois
    • Chicago, Illinois, United States
      • The University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States
      • Indiana Unveresity Hospital
  • Iowa
    • Clive, Iowa, United States
      • Iowa Digestive Disease Center
  • Maryland
    • Baltimore, Maryland, United States
      • University of Maryland Medical Center
    • Chevy Chase, Maryland, United States
      • Metropolitan Gastroenterology Group
  • Michigan
    • Michigan, Michigan, United States
      • Digestive Health Center of Michigan
  • New Jersey
    • Morristown, New Jersey, United States
      • Atlantic Health System Morristown Memorial Pediatric GE
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • UNC Chapel Hill
  • Ohio
    • Dayton, Ohio, United States, 45440
      • Dr. Romeo, Dayton Gastroenterology
  • Virginia
    • Chesapeake, Virginia, United States
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Capsule endoscopy	Device: Capsule endoscopy and Ileocolonoscopy tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)	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	6 months changefrom Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes	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	Baseline
Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum	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	6 months change from Baseline
Evaluate the Entire SB CE Scores	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	6 months change from Baseline
Adverse Events (AE)	To assess safety related to capsule retention and other adverse events	6 months

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Gil Melmed, MD, Cyder Cinai LA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: April 30, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: MA-209