An interventional study of IBDoc calprotectin test and questionnaire in Inflammatory Bowel Diseases, sponsored by Bühlmann Laboratories AG. Completed at 3 sites in Canada. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by Bühlmann Laboratories AG · Not applicable, Interventional, and Diagnostic
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.
The patient will determine the calprotectin concentration in their own stool sample using the IBDoc® assay. For this, the patient will collect a stool sample in a standard collection tube at home. The patients will return to the clinical site with the specimen, where they will receive a standardized IBDoc® training. They will also be given opportunity to perform an IBDoc® practice test using the collected sample. The patients will then perform the full IBDoc® assay using the collected stool sample under the observation of the healthcare provider, who will assess their performance. The final result - the interpretation of the IBDoc® lateral flow assay by the CalApp® smartphone application, to yield a final μg/g calprotectin concentration in stool, will be sent to the health care provider (HCP) via the IBDoc® Web Portal.
The usability of the IBDoc® test will be evaluated according to the following factors:
To exclude bias or inaccuracy that may arise from the analytical performance characteristics of the IBDoc® assay itself, a comparative IBDoc® assay will be performed according to the instructions for use, with the patients' samples in a laboratory. For the comparative IBDoc® measurement the HCP at the clinical site will obtain one CALEX® Valve extract from the patient's stool sample, which will be stored frozen and shipped to the laboratory site.
-IBDoc® Calprotectin test usability, clearness of obtained result, and comprehensiveness of the Instruction for Use will be assessed in the following ways:
The ability of patients to correctly collect and extract stool samples using the CALEX® Valve device will be analysed as an additional module within the IBDoc® User Performance Evaluation. The CALEX® Valve extracts obtained by the patients as part of the IBDoc® procedure will be stored frozen and shipped to the laboratory site. Calprotectin levels in the patients' CALEX® Valve extracts will be determined with the BÜHLMANN fCAL® ELISA and compared to calprotectin reference values obtained from the same stool samples by the HCP's.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's enrollment of 61 is below the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Bühlmann Laboratories AG is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IBD patients performing IBDoc calprotectin test and ease-of-use questionnaires
Diagnostic Test: IBDoc calprotectin test · Other: questionnaire
Patients are asked to perform a single IBDoc calprotectin home test.
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.
Trueness/ accuracy of patients IBDoc® results
Patients' IBDoc results are compared to reference calprotectin values obtained by laboratory methods
Time frame: 24 hours
Quantifiable feedback from the enrolled patients about the ease-of-use of the test
Ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use is assessed in a questionnaire, with 12 statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating patients will be evaluated for each statement.
Time frame: 24 hours
Quantifiable feedback from healthcare providers
Quantifiable feedback from the healthcare providers about the ability of the patients to correctly perform the IBDoc® assay. Assessment will be made through a questionnaire with five (5) statements, scored on a 1-to-5 Likert scale, with one (1) indicating "I strongly disagree" and five (5) "I strongly agree". The mean and standard deviation of scores obtained from all participating healthcare providers will be evaluated for each statement.
Time frame: 24 hours
Ran from May 2017 to primary completion in Aug 2017, 3 months.
Of 296 interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 3 months is below that.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Bühlmann Laboratories AG