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Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's A Pilot Study

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ClinicalTrials.gov Identifier: NCT02303756
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Niels Qvist, Odense University Hospital

Brief Summary:
The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

Condition or disease Intervention/treatment Phase
Rectal Bleeding Device: Pillcam® COLON Capsule Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pillcam® COLON Capsule
Detection of neoplastic lesions in colon and rectum compared to colonoscopy
Device: Pillcam® COLON Capsule
colonoscopy




Primary Outcome Measures :
  1. Identification of neoplasia [ Time Frame: One week after examination ]
    Compared to colonoscopy


Secondary Outcome Measures :
  1. Completion rate [ Time Frame: 24 hours ]
    Documented capsule excretion on the viedorecordin



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Positive feaecal occult bleeding test at screening

Exclusion Criteria:

  • Previous gastrointestinal surgery except for appendectomy
  • Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
  • An ostomy
  • Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
  • Vomiting in connection with the bowel emptying procedure

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): NCT02303756


Locations
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Denmark
Odesne University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Niels Qvist, professor Odense University Hospital