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.
BLINK
Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease
1 other identifier
interventional
187
3 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedResults Posted
Study results publicly available
June 9, 2020
CompletedJune 9, 2020
October 1, 2019
1.5 years
July 24, 2017
May 11, 2020
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.
Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score
Baseline
Secondary Outcomes (3)
Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.
Baseline
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE
Baseline
Patient Satisfaction
After completion of final procedure, either the same day or by the next business day following procedure completion.
Study Arms (1)
MRE, Patency Capsule (if needed), CE, and IC
OTHERSingle-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
Interventions
At baseline subject will under the PillCam Crohn's Capsule Procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (26)
University of South Alabama
Mobile, Alabama, 36688, United States
Mayo Clinic (Scottsdale, AZ)
Scottsdale, Arizona, 85259, United States
Encore Borland Groover Clinical Research
Jacksonville, Florida, 32256, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
Loyola University - Chicago
Maywood, Illinois, 60153, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
University of Kansas
Kansas City, Kansas, 66160, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic (Rochester, MN)
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Atlantic Health (Morristown)
Morristown, New Jersey, 07962, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Digestive Disease Specialists Inc.
Oklahoma City, Oklahoma, 73112, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Carilion Clinic
Roanoke, Virginia, 24016, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Allgemeines Krankenhaus - Universitatskliniken Wein
Vienna, 1090, Austria
Sheba Medical Center
Tel Litwinsky, Ramat Gan, 5265601, Israel
Related Publications (1)
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.
PMID: 32499275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amanda Wenisch, Clinical Resaerch Coordinator / Study Manager
- Organization
- Medtronic GIH
Study Officials
- PRINCIPAL INVESTIGATOR
David Bruining, MD
Mayo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 7, 2017
Study Start
December 21, 2017
Primary Completion
June 20, 2019
Study Completion
June 20, 2019
Last Updated
June 9, 2020
Results First Posted
June 9, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share