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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 : Recruiting
First Posted : August 7, 2017
Last Update Posted : June 27, 2018
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 and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12 month follow ups.


Condition or disease Intervention/treatment Phase
Crohn Disease Device: Capsule Endoscopy Device: Comparator Group: IC plus MRE or IC alone Not Applicable

Detailed Description:

This is a multicenter, prospective, randomized 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) 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, Quality of life questionnaire and Adverse Events.

Subjects who do not have active CD, as assessed by all three modalities, will be discontinued from the study.

Subjects with confirmed active CD will then be randomized into two groups a) CE and b) IC plus MRE or IC alone (comparator group). In the comparator group, subjects with small bowel disease (proximal and/or ileal) and/or colonic disease with clinical indication (per investigator discretion) will undergo IC plus MRE. For subjects with no small bowel, MRE at 6 and 12 months is at the discretion of the physician.

At 6 and 12 month follow up appointments, subjects will return for follow up visits. At 3 and 9 month follow up appointments will be conducted over the phone.

At 6 and 12 month follow up appointments, subjects will undergo a second round of procedure/s with either CE or IC with or without MRE. The following assessments will also take place at the 6 and 12 month follow up appointments: Laboratory tests, Pregnancy test, Concomitant medications, Patient satisfaction questionnaire, Adverse events. In addition at the 12 month follow up visit the Quality of Life Questionnaire will be completed as well.

At 3 and 9 month follow up phone calls the information to be collected are as follows: Concomitant medications and Adverse Events.

All CE and IC videos and MRE images will be evaluated by central readers. A 1:1 randomization will be employed to minimize bias relative to the comparison of the two study arms. In addition, CE and IC videos and MRE images will be randomly distributed among the central readers.

The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the United States, Israel, and Europe (Austria, Italy, Portugal, France, Germany). Study duration is expected to be up to approximately 3 years. Subjects will be followed for a period of 12 months in order to effectively evaluate changes to the disease state. The expected duration of each subject's participation is approximately 13 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicenter, Prospective, Randomized 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
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Capsule Endoscopy
This group will receive the Capsule Endoscopy procedure at 6 and 12 month follow up visits.
Device: Capsule Endoscopy
At follow up visits 6 and 12 months study subjects in this group will undergo PillCam patency study at the discretion of the investigator and will undergo capsule endoscopy.
Other Name: PillCam Crohn's® Capsule

Comparator Group (IC plus MRE or IC alone)
This group will receive ileocolonoscopy (IC) plus MRE or IC alone at 6 and 12 month follow up visits.
Device: Comparator Group: IC plus MRE or IC alone
At follow up visits 6 and 12 months study subjects in this group will undergo IC with or without MRE procedures. Subjects with small bowel disease (proximal and/or ileal) and/or colonic disease with clinical indication (per investigator discretion) will undergo IC plus MRE. For subjects with no small bowel disease, MRE at 6 and 12 months is at the discretion of the physician.




Primary Outcome Measures :
  1. Primary endpoint is the sensitivity for detecting active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: This will be measured at baseline ]
    Presence of active CD will be used to calculate accuracy measures comparing CE to IC plus MRE. Active CD will be assessed based on the following scores: the Lewis Score will be used to evaluate the proximal small bowel and the terminal ileum with CE; the SES-CD scores will be used to evaluate both the terminal ileum and the colon with CE and IC; and the MaRIA score will be used to evaluate the small bowel (proximal and terminal ileum) with MRE.

  2. Primary endpoint is the sensitivity for detecting active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: This will be measured at 6- month follow up ]
    Presence of active CD will be used to calculate accuracy measures comparing CE to IC plus MRE. Active CD will be assessed based on the following scores: the Lewis Score will be used to evaluate the proximal small bowel and the terminal ileum with CE; the SES-CD scores will be used to evaluate both the terminal ileum and the colon with CE and IC; and the MaRIA score will be used to evaluate the small bowel (proximal and terminal ileum) with MRE.

  3. Primary endpoint is the sensitivity for detecting active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: This will be measured at 12 month follow up ]
    Presence of active CD will be used to calculate accuracy measures comparing CE to IC plus MRE. Active CD will be assessed based on the following scores: the Lewis Score will be used to evaluate the proximal small bowel and the terminal ileum with CE; the SES-CD scores will be used to evaluate both the terminal ileum and the colon with CE and IC; and the MaRIA score will be used to evaluate the small bowel (proximal and terminal ileum) with MRE.


Secondary Outcome Measures :
  1. Specificity, negative predictive value (NPV), and positive predictive value (PPV) value for active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: This will be measured at baseline, 6 month follow up and 12 month follow up ]
    Accuracy measures (sensitivity, specificity, negative predictive value, positive predictive value) will be calculated for the overall bowels (small bowel and colon) as well as for the designated bowel segments (proximal small bowel, terminal ileum, and colon). Once accuracy is defined in each segment, the data will be aggregated to measure accuracy for the overall bowels. If there is any positive finding of active CD in any of the three designated segments (proximal small bowel, terminal ileum, colon), it will be counted as positive for overall accuracy.

  2. Sensitivity, specificity, NPV, and PPV for active CD in designated bowel segments (proximal small bowel, terminal ileum, and colon) by CE compared to IC plus MRE [ Time Frame: This will be measured at baseline, 6 month follow up and 12 month follow up ]
    Accuracy measures (sensitivity, specificity, negative predictive value, positive predictive value) will be calculated for the overall bowels (small bowel and colon) as well as for the designated bowel segments (proximal small bowel, terminal ileum, and colon). Once accuracy is defined in each segment, the data will be aggregated to measure accuracy for the overall bowels. If there is any positive finding of active CD in any of the three designated segments (proximal small bowel, terminal ileum, colon), it will be counted as positive for overall accuracy.

  3. Assessment of mucosal disease activity at baseline and 6 and 12-month follow ups [ Time Frame: This will be measured at baseline, 6 month follow up and 12 month follow up ]
    Mucosal disease activity will be measured based on the score from the Lewis score to evaluate the proximal small bowel and terminal ileum with CE

  4. Assessment of mucosal disease activity at baseline and 6 and 12-month follow ups [ Time Frame: This will be measured at baseline, 6 month follow up and 12 month follow up ]
    Mucosal disease activity will be measured based on the SES-CD scores to evaluate both the terminal ileum and colon with CE and IC

  5. Assessment of mucosal disease activity at baseline and 6 and 12-month follow ups [ Time Frame: This will be measured at baseline, 6 month follow up and 12 month follow up ]
    Mucosal disease activity will be measured based on the MaRIA score to evaluate the small bowel (proximal and terminal ileum) with MRE.

  6. Patient satisfaction at baseline and 6 - and 12- month follow up visits [ Time Frame: The questionnaires will be completed at baseline, 6 month and 12 month follow ups. ]
    The BLINK Patient Satisfaction Questionnaire will be used.

  7. Quality of life at baseline and 12- month follow up [ Time Frame: This will be collected at baseline and at 12 month follow up. ]
    The EQ-5D (adult version) will be used.

  8. Quality of life at baseline and 12- month follow up [ Time Frame: This will be collected at baseline and at 12 month follow up. ]
    IBD Questionnaire (IBDQ) short version will be used.

  9. Concomitant medication [ Time Frame: This information will be collected at baseline, 3, 6, 9, and 12 month follow ups ]
    All current medications, including type and dose will need to be reported. It will be specified whether the medication is related/non-related Crohn's Disease medication.



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 (diagnosis based on radiologic, endoscopic, or histological evidence).

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.
  • Subjects with a history of small bowel or colonic resection.
  • Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, 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 descretion

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


Contacts
Contact: Jessica Carlson 203-640-9644 jessica.a.carlson@medtronic.com
Contact: Jennifer Kruszewski 860-800-4477 jennifer.kruszewski@medtronic.com

Locations
United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36688
Contact: Carla Huber    251-660-5555    chuber@health.southalabama.edu   
Contact: Ashley Stone    251-660-5555    ahstone@health.southalabama.edu   
United States, Florida
Borland Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
Contact: Latashia Hundley    904-680-0871    lhundley01@borlandgroover.com   
Shafran Gastroenterology Center Recruiting
Winter Park, Florida, United States, 32789
Contact: Amy Liebmann    407-629-8121    aliebmann3225@gmail.com   
Contact: Sarah Jones    407-629-8121    sarah@shafran.net   
United States, Illinois
Loyola University - Chicago Recruiting
Maywood, Illinois, United States, 60153
Contact: Elizabeth Kirwan    708-216-2057    ekirwan@luc.edu   
Contact: Jeanne Cerceo    708-216-2057    jcerceo@luc.edu   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Debbie Drenzyk, RN    317-948-9212    robinsd@iu.edu   
Indianapolis Gastroenterology Research Foundation Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Sheila Thompson    317-865-2959    sthompson@indygastro.com   
Contact: Beverly Flamme    317-865-2959    bflamme@indygastro.com   
United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Olivia Price       oprice2@kumc.edu   
United States, Minnesota
Mayo Clinic (Rochester, MN) Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brenda Becker    507-284-0959    becker.brenda1@mayo.edu   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Susan Jones    314-362-8412    jonessusan@wustl.edu   
United States, New Jersey
Atlantic Health (Morristown) Recruiting
Morristown, New Jersey, United States, 07962
Contact: Fatima Intikhab    973-630-2232    Fatima.intikhab@atlantichealth.org   
Contact: Veronique Ruppe    973-829-4869    Veronique.Ruppe@atlantichealth.org   
United States, North Carolina
Asheville Gastroenterology Associates, PA Recruiting
Asheville, North Carolina, United States, 28801
Contact: Susan Westcott    828-350-3667    swestcott@ncdhp.com   
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ashley Hatcher    614-293-2566    ashley.hatcher@osumc.edu   
Contact: Casey McClurkin    614-688-9575    Casey.McClurkin@osumc.edu   
United States, Virginia
Gastroenterology Associates of Tidewater Recruiting
Chesapeake, Virginia, United States, 23320
Contact: Jo-Anne Tiamzon    757-547-0798 ext 1109    JTiamzon@gatgi.com   
Contact: MariCarmen Korngiebel-Rosique    757-547-0798 ext 1122    Mkorngiebel-Rosique@gatgi.com   
Virginia Gastroenterology Institute Recruiting
Suffolk, Virginia, United States, 23434
Contact: Crystal Beaber    757-469-4163    cbeaber@virginiagastro.com   
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Ramat Gan, Israel, 5265601
Contact: Nina Levhar    97235307072    nina.levhar@sheba.health.gov.il   
Contact: Limor Selinger    97235307072    limor.selinger@sheba.health.gov.il   
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: David Bruining, MD Mayo

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: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases