Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.

NCT ID: NCT03241368

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2019-06-20

Brief Summary

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.

The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease.

There will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.

Detailed Description

This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known CD and mucosal disease.

A screening visit will be performed within 30 days prior to baseline procedures to assess pre-procedure eligibility. At this visit the following assessments will be performed: Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification, Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy tests.

At baseline, subjects with known CD on routine evaluation (e.g. history, physical exams, labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease based on clinical judgment based on symptoms, laboratory data or other clinical information will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel. Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events (AE).

Subjects will be exited from the study once all Baseline Procedures have been completed and AEs resolved.

All CE videos, IC videos and MRE images will be evaluated by central readers.

The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5 years. The expected duration of each subject's participation is approximately 1 month.

Conditions

Crohn Disease

Study Design

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

Study Groups

MRE, Patency Capsule (if needed), CE, and IC

Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.

Group Type: OTHER

Capsule Endoscopy

Intervention Type: DEVICE

At baseline subject will under the PillCam Crohn's Capsule Procedure

Interventions

Capsule Endoscopy

At baseline subject will under the PillCam Crohn's Capsule Procedure

Intervention Type: DEVICE

Other Intervention Names

PillCam Crohn's® Capsule

Eligibility Criteria

Inclusion Criteria

• Subject has provided informed consent.
• Subject is ≥ 18 years of age
• Subject is willing and able to comply with all aspects of treatment and evaluation schedule.
• Subject has known CD and a recent history (within last 2 years) of mucosal disease (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information.

Exclusion Criteria

• Subject has indeterminate, ulcerative, antibiotic-associated colitis.
• Subject has stool positive for ova and parasite and for Clostridium difficile toxins within 3 months prior to enrollment.
• Subject with other known infectious cause of abdominal symptoms.
• Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range.
• Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
• Subject with suspected or known bowel obstruction, stricture (defined as unequivocal proximal upstream dilation equal ≥ 2.5 cm), or fistula.
• Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (≤ 100 mg daily) are acceptable and not exclusionary.
• Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions.
• Subject with cardiac pacemaker or other implanted electromedical device.
• Subject has an allergy or other known contraindication to the medications used in the study.
• Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
• Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity).
• Subject has a known contraindication to MRE or IC.
• Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study.
• Subject has any medical condition that would make it unsafe for them to participate, per Investigator's discretion
• Subject with ileostomy or colostomy, history of total or subtotal colectomy (including those with ileosigmoidostomy, and ileorectostomy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bruining, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo

Locations

University of South Alabama

Mobile, Alabama, United States

Mayo Clinic (Scottsdale, AZ)

Scottsdale, Arizona, United States

Encore Borland Groover Clinical Research

Jacksonville, Florida, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Loyola University - Chicago

Maywood, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, United States

University of Kansas

Kansas City, Kansas, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic (Rochester, MN)

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Atlantic Health (Morristown)

Morristown, New Jersey, United States

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Digestive Disease Specialists Inc.

Oklahoma City, Oklahoma, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Virginia Gastroenterology Institute

Suffolk, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Allgemeines Krankenhaus - Universitatskliniken Wein

Vienna, , Austria

Sheba Medical Center

Tel Litwinsky, Ramat Gan, Israel

Countries

United States; Austria; Israel

References

Bruining DH, Oliva S, Fleisher MR, Fischer M, Fletcher JG; BLINK study group. Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study. BMJ Open Gastroenterol. 2020 Jun;7(1):e000365. doi: 10.1136/bmjgast-2019-000365.

Reference Type: DERIVED

PMID: 32499275 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COVSBCC0549

Identifier Type: -

Identifier Source: org_study_id