CompletedNCT03241368BLINKUpdated Jun 9, 2020Results posted

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.

An interventional study of Capsule Endoscopy in Crohn Disease, sponsored by Medtronic - MITG. Completed at 26 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by Medtronic - MITG · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 187
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Crohn Disease

Browse trials for

Crohn Disease 1,880

Keywords

Irritable Bowel Disease
IBD
Mucosal Disease
Crohn's
Inflammatory Bowel Disease

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 187 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 187 participants (actual)

Study arms

Other
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.
Device: Capsule Endoscopy

Interventions

DeviceCapsule Endoscopy
At baseline subject will under the PillCam Crohn's Capsule Procedure
Also known as: PillCam Crohn's® Capsule

What researchers measure

Primary outcomes

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
Time frame: Baseline

Secondary outcomes

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
Time frame: 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
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
Patient Satisfaction
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.

Results

Posted Jun 9, 2020

Participant flow

187 subjects signed consent. Per the protocol, a subject was not considered "enrolled" until consent was signed and subject met inclusion/exclusion criteria. Of the 187 who signed consent, 158 were considered "enrolled" per the protocol. 29 were "screen failures", i.e. they signed informed consent, but ended up failing inclusion/exclusion.

Participant flow — Overall Study
Milestone	MRE, Patency Capsule (if Needed), CE, and IC
Started	158
Completed	119
Not completed	39
Withdrew: Mre stricture or patency capsule failure	25
Withdrew: Lost to follow-up	1
Withdrew: Physician decision	6
Withdrew: Withdrawal by subject	6
Withdrew: Protocol violation	1

Outcome measures

PrimaryAccuracy 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

Time frame:: Baseline
Reported as:: Mean · percentage of participants

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.
percentage of participants	MRE, Patency Capsule (if Needed), CE, and IC
Sensitivity CE Overall	94 (86 to 98)
Sensitivity MRE + IC Overall	100 (95 to 100)
Specificity CE Overall	74 (55 to 87)
Specificity MRE + IC Overall	22 (10 to 41)

Statistical analysis

MRE, Patency Capsule (if Needed), CE, and IC · McNemar · p = 0.125Exact McNemar's test

SecondarySpecificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.

Time frame:: Baseline
Reported as:: Mean · percentage of participants

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.
percentage of participants	MRE, Patency Capsule (if Needed), CE, and IC
Specificity	74 (55 to 87)
Negative Predictive Value (NPV)	83 (64 to 94)
Positive Predictive Value (PPV)	91 (82 to 96)

SecondarySensitivity, 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

Time frame:: Baseline
Reported as:: Mean · percentage of participants

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
percentage of participants	MRE, Patency Capsule (if Needed), CE, and IC
Sensitivity CE Proximal Small Bowel (PSB)	97 (82 to 100)
Sensitivity MRE PSB	71 (53 to 84)
Specificity CE PSB	87 (76 to 93)
Specificity MRE PSB	66 (54 to 76)
NPV CE PSB	98 (90 to 100)
NPV MRE PSB	83 (71 to 91)
PPV CE PSB	77 (62 to 88)
PPV MRE PSB	49 (35 to 63)
Sensitivity CE Terminal ilium (TI)	94 (84 to 99)
Sensitivity MRE + IC TI	98 (89 to 100)
Specificity CE TI	82 (66 to 91)
Specificity MRE + IC TI	37 (23 to 53)
NPV CE TI	91 (76 to 98)
NPV MRE + IC TI	93 (68 to 100)
PPV CE TI	88 (76 to 94)
PPV MRE + IC TI	68 (57 to 78)
Sensitivity CE Colon	83 (62 to 94)
Sensitivity IC Colon	91 (72 to 99)
Specificity CE Colon	88 (77 to 94)
Specificity IC Colon	89 (79 to 95)
NPV CE Colon	93 (84 to 98)
NPV IC Colon	97 (88 to 100)
PPV CE Colon	70 (51 to 84)
PPV IC Colon	75 (56 to 88)

SecondaryPatient Satisfaction

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.
Reported as:: Count of participants · Participants

Patient Satisfaction
Participants	MRE, Patency Capsule (if Needed), CE, and IC
Preferred PillCam CE	64
Preferred IC	43
Preferred MRE + IC	11

Adverse events

Collected over 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MRE, Patency Capsule (if Needed), CE, and IC	0/119 (0%)	7/119 (5.9%)	11/119 (9.2%)

Most frequent serious events

Most frequent serious events
Event	MRE, Patency Capsule (if Needed), CE, and IC
Crohn's DiseaseGastrointestinal disorders	3/119
Abdominal painGastrointestinal disorders	1/119
Complication of device removalGeneral disorders	1/119
Clostridium difficile infectionInfections and infestations	1/119
Serum sicknessImmune system disorders	1/119

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	MRE, Patency Capsule (if Needed), CE, and IC
Abdominal painGastrointestinal disorders	1/119
ConstipationGastrointestinal disorders	1/119
HaematocheziaGastrointestinal disorders	1/119
HaemorrhoidsGastrointestinal disorders	1/119
Infusion site extravasationGeneral disorders	1/119
Oesophageal candidiasisInfections and infestations	1/119
Staphylococcal skin infectionInfections and infestations	1/119
Infusion related reactionInjury, poisoning and procedural complications	1/119
Post procedural complicationInjury, poisoning and procedural complications	1/119
Haemoglobin decreasedInvestigations	1/119

Baseline characteristics

Per-protocol analysis set, included subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) with no major protocol deviations (violations that may have significant impact on outcomes) and did not meet the following: subject withdraw; capsule remained in stomach or small bowel for entire procedure; system technical failure

Age, Categorical
Age, Categorical(Participants)	MRE, Patency Capsule (if Needed), CE, and IC
<=18 years	0
Between 18 and 65 years	96
>=65 years	3

Sex: Female, Male
Sex: Female, Male(Participants)	MRE, Patency Capsule (if Needed), CE, and IC
Female	63
Male	36

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	MRE, Patency Capsule (if Needed), CE, and IC

Region of Enrollment
Region of Enrollment(participants)	MRE, Patency Capsule (if Needed), CE, and IC
Austria	2
United States	95
Israel	2

BMI
BMI(kg/m²)	MRE, Patency Capsule (if Needed), CE, and IC
Mean	28.82 ± 7.36

Study locations

26 sites

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
Saint 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 Hashomer, Ramat Gan 5265601, Israel

References and documents

Publications

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. PubMed 32499275 ↗

Study documents

Protocol and statistical analysis plan · Nov 16, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03241368
Lead sponsor: Medtronic - MITG
Responsible party: Sponsor
First posted: Aug 7, 2017
Start date: Dec 21, 2017
Primary completion: Jun 20, 2019
Completion: Jun 20, 2019
Results posted: Jun 9, 2020
Last update: Jun 9, 2020

Study contacts

David Bruining, MD

principal investigator · Mayo

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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