Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
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ClinicalTrials.gov Identifier: NCT01942720 |
Recruitment Status :
Completed
First Posted : September 16, 2013
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Known Crohn Disease Subjects | Device: Capsule endoscopy and Ileocolonoscopy tests | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | N/A |
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 |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Capsule endoscopy |
Device: Capsule endoscopy and Ileocolonoscopy tests |
- 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
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject ages 2-75 years, inclusive
- Subjects with a diagnosis of known Crohn disease
- Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
- 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.
- Subject or parent agrees to sign consent form
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
- Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
- Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
- Stricture seen on radiological exam.
- Indeterminate Colitis
- Ulcerative Colitis
- Antibiotic Associated Colitis
- Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
- Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
- Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subjects with known or suspected delayed gastric emptying
- Subjects with known or suspected delayed Small bowel motility
- Subject has any allergy or other known contraindication to the medications used in the study.
- 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.
- Unwillingness to use a medically accepted method of contraception throughout duration of study
- Concurrent participation in another clinical trial using any investigational drug or device.
- Subject has cardiac pacemaker or other implanted electromedical devices
- Subject suffers from a life threatening condition.
- Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
- Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

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
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 |
Principal Investigator: | Jonathan Leighton, MD | Mayo Clinic | |
Principal Investigator: | Gil Melmed, MD | Cyder Cinai LA |
Responsible Party: | Medtronic - MITG |
ClinicalTrials.gov Identifier: | NCT01942720 |
Other Study ID Numbers: |
MA-209 |
First Posted: | September 16, 2013 Key Record Dates |
Results First Posted: | May 31, 2017 |
Last Update Posted: | May 31, 2017 |
Last Verified: | August 2016 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |