Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Given Imaging Ltd.
Information provided by (Responsible Party):
Given Imaging Ltd. Identifier:
First received: September 11, 2013
Last updated: February 23, 2015
Last verified: February 2015

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 Phase
Known Crohn Disease Subjects
Device: Capsule endoscopy and Ileocolonoscopy tests
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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 Given Imaging Ltd.:

Primary Outcome Measures:
  • mucosal change in VCE mucosal scores and PGA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure

Secondary Outcome Measures:
  • correlation between SES CD score and capsule scoring indexes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI at baseline.

  • correlation between the change in SES CD score and the change in capsule scoring indexes- in terminal ileum [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Evaluate the entire SB CE Scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS)

  • safety related to capsule [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To assess safety related to capsule retention and other adverse events

Estimated Enrollment: 75
Study Start Date: August 2013
Estimated Study Completion Date: July 2016
Estimated 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


Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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, 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01942720

Contact: Ravit Peled +972-4-9097894

United States, Arizona
Mayo Clinic Recruiting
Scottsdale, AZ, Arizona, United States
Contact: Grant Erickson         
Principal Investigator: Shabbana Pasha, MD         
United States, California
Cedars Sinai Medical Center Recruiting
LA, California, United States
Contact: Cynthia Walsh         
Principal Investigator: Gil Melmed, MD         
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
Contact: Laura Walter         
Principal Investigator: Mark Fleisher, MD         
Shafran Gastroenterology Center Recruiting
Winter Park, Florida, United States
Contact: kara Fitch         
Principal Investigator: Irra Shafran, MD         
United States, Georgia
Children's Center for Digestive Healthcare Recruiting
Atlanta, Georgia, United States
Contact: Angela Stallworth         
Principal Investigator: Stan Cohen         
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Rose Arrieta         
Principal Investigator: Sakuraba Atsushi, MD         
United States, Indiana
Indiana Unveresity Hospital Recruiting
Indianapolis, Indiana, United States
Contact: Gewn Coock         
Principal Investigator: Debra Helper, MD         
United States, Iowa
Iowa Digestive Disease Center Recruiting
Clive, Iowa, United States
Contact: Jene Formaro         
Principal Investigator: Bernard Leman, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States
Contact: Guruprasad Jambaulikar         
Principal Investigator: Gahazi, MD         
Metropolitan Gastroenterology Group Recruiting
Chevy Chase, Maryland, United States
Contact: Cindy coates         
Principal Investigator: Robert Hardi, MD         
United States, Michigan
Digestive Health Center of Michigan Recruiting
Michigan, Michigan, United States
Contact: Joe Palmer         
Principal Investigator: Robert Fogel, MD         
United States, New Jersey
Atlantic Health System Morristown Memorial Pediatric GE Recruiting
Morristown, New Jersey, United States
Contact: Annette Langseder         
Principal Investigator: Joel Rosh, MD         
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States
Contact: Paris Laliberte         
Principal Investigator: Kim Isaacs, MD         
United States, Ohio
Dr. Romeo, Dayton Gastroenterology Recruiting
Dayton, Ohio, United States, 45440
Contact: Susan Kesler         
Principal Investigator: David Romeo, MD         
United States, Virginia
Gastroenterology Associates of Tidewater Recruiting
Chesapeak, Virginia, United States
Contact: JoAnne Tiamzon         
Principal Investigator: Malik Pramod, MD         
Sponsors and Collaborators
Given Imaging Ltd.
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Gil Melmed, MD Cyder Cinai LA
  More Information

No publications provided

Responsible Party: Given Imaging Ltd. Identifier: NCT01942720     History of Changes
Other Study ID Numbers: MA-209
Study First Received: September 11, 2013
Last Updated: February 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases processed this record on February 25, 2015