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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01942720
First Posted: September 16, 2013
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
  Purpose
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Condition Intervention
Known Crohn Disease Subjects Device: Capsule endoscopy and Ileocolonoscopy tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) [ Time Frame: 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:
  • Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes [ Time Frame: 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


  • Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum [ Time Frame: 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

  • Evaluate the Entire SB CE Scores [ Time Frame: 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


  • Adverse Events (AE) [ Time Frame: 6 months ]
    To assess safety related to capsule retention and other adverse events


Enrollment: 74
Study Start Date: August 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Capsule endoscopy 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942720


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
United States, Georgia
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
United States, Illinois
The University of Chicago
Chicago, Illinois, United States
United States, Indiana
Indiana Unveresity Hospital
Indianapolis, Indiana, United States
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
United States, Michigan
Digestive Health Center of Michigan
Michigan, Michigan, United States
United States, New Jersey
Atlantic Health System Morristown Memorial Pediatric GE
Morristown, New Jersey, United States
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States
United States, Ohio
Dr. Romeo, Dayton Gastroenterology
Dayton, Ohio, United States, 45440
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Gil Melmed, MD Cyder Cinai LA
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01942720     History of Changes
Other Study ID Numbers: MA-209
First Submitted: September 11, 2013
First Posted: September 16, 2013
Results First Submitted: December 22, 2016
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases