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

NCT ID: NCT01942720

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-07-31

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

Conditions

Known Crohn Disease Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Capsule endoscopy

Group Type: OTHER

Capsule endoscopy and Ileocolonoscopy tests

Intervention Type: DEVICE

Interventions

Capsule endoscopy and Ileocolonoscopy tests

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Leighton, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Gil Melmed, MD

Role: PRINCIPAL_INVESTIGATOR

Cyder Cinai LA

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

Indiana Unveresity Hospital

Indianapolis, Indiana, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Metropolitan Gastroenterology Group

Chevy Chase, Maryland, United States

Digestive Health Center of Michigan

Michigan, Michigan, United States

Atlantic Health System Morristown Memorial Pediatric GE

Morristown, New Jersey, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Dr. Romeo, Dayton Gastroenterology

Dayton, Ohio, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30086261 (View on PubMed)

Other Identifiers

MA-209

Identifier Type: -

Identifier Source: org_study_id