Back to resultsClinical 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)
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Capsule Endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease focused on measuring Irritable Bowel Disease, IBD, Mucosal Disease, Crohn's, Inflammatory Bowel Disease
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)
Sites / Locations
- University of South Alabama
- Mayo Clinic (Scottsdale, AZ)
- Encore Borland Groover Clinical Research
- Children's Center for Digestive Healthcare
- Loyola University - Chicago
- Indiana University
- Indianapolis Gastroenterology Research Foundation
- University of Kansas
- Louisiana State University Health Science Center
- University of Massachusetts Memorial Medical Center
- University of Michigan
- Mayo Clinic (Rochester, MN)
- Washington University
- Atlantic Health (Morristown)
- Asheville Gastroenterology Associates, PA
- University Hospitals Cleveland Medical Center
- The Ohio State University Medical Center
- Digestive Disease Specialists Inc.
- Hospital of the University of Pennsylvania
- Gastroenterology Associates of Tidewater
- Carilion Clinic
- Virginia Gastroenterology Institute
- Virginia Mason Medical Center
- Medical College of Wisconsin
- Allgemeines Krankenhaus - Universitatskliniken Wein
- Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRE, Patency Capsule (if needed), CE, and IC
Arm Description
Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
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
Patient Satisfaction
Patient preference of which procedure they preferred (CE, IC or MRE plus IC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241368
Brief Title
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.
Acronym
BLINK
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Irritable Bowel Disease, IBD, Mucosal Disease, Crohn's, Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRE, Patency Capsule (if needed), CE, and IC
Arm Type
Other
Arm Description
Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
Intervention Type
Device
Intervention Name(s)
Capsule Endoscopy
Other Intervention Name(s)
PillCam Crohn's® Capsule
Intervention Description
At baseline subject will under the PillCam Crohn's Capsule Procedure
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Baseline
Title
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
Description
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
Time Frame
Baseline
Title
Patient Satisfaction
Description
Patient preference of which procedure they preferred (CE, IC or MRE plus IC)
Time Frame
After completion of final procedure, either the same day or by the next business day following procedure completion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bruining, MD
Organizational Affiliation
Mayo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Mayo Clinic (Scottsdale, AZ)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Encore Borland Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Children's Center for Digestive Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Loyola University - Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic (Rochester, MN)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Atlantic Health (Morristown)
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Digestive Disease Specialists Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Virginia Gastroenterology Institute
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23434
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Allgemeines Krankenhaus - Universitatskliniken Wein
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Sheba Medical Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32499275
Citation
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.
Results Reference
derived
Learn more about this trial
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.
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