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IBDoc® Canadian User Performance Evaluation

NCT03408249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-01-24

No results posted yet for this study

Summary

The objective of the IBDoc® user performance evaluation is to demonstrate the ease-of-use of the IBDoc® calprotectin home test to allow patients with inflammatory bowel disease (IBD) to independently and correctly determine calprotectin concentration in their own stool sample. The study is based on Chapter 8 of the International Organization for Standardization (ISO) Standard, ISO 15197:2013 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The study is a prospective, multicenter study, not blinded for patients, and includes a total of 61 patients.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DIAGNOSTIC_TEST

IBDoc calprotectin test

Patients are asked to perform a single IBDoc calprotectin home test.

OTHER

questionnaire

Patients evaluate the ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use through a specific questionnaire implementing Likert scales.

Sponsors & Collaborators

  • Bühlmann Laboratories AG

    lead INDUSTRY

Principal Investigators

  • Greg Rosenfeld, MD · GIRI (GI Research Institute), Vancouver, Canada

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2017-08-22
Completion
2017-08-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408249 on ClinicalTrials.gov