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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)

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ClinicalTrials.gov Identifier: NCT03241368
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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.


Condition or disease Intervention/treatment Phase
Crohn Disease Device: Capsule Endoscopy Not Applicable

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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Baseline
Baseline visit includes MRE procedure, PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
Device: Capsule Endoscopy
At baseline subject will under the PillCam Crohn's Capsule Procedure
Other Name: PillCam Crohn's® Capsule




Primary Outcome Measures :
  1. Sensitivity for detecting active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: Baseline ]
    Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score


Secondary Outcome Measures :
  1. 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. [ Time Frame: Baseline ]
    Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score

  2. Senstivity, 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 ]
    Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 difficule 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241368


  Show 26 Study Locations
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: David Bruining, MD Mayo

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03241368     History of Changes
Other Study ID Numbers: COVSBCC0549
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medtronic - MITG:
Irritable Bowel Disease
IBD
Mucosal Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases