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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02149043 |
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Date of registration:
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20/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Thermography in Surveillance of Ulcerative Colitis
Thermo |
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Scientific title:
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Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02149043 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Marko Banic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Dubrava |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Endoscopic diagnosis of active extensive ulcerative colitis
- Stool Calprotectin > 150 mcg/g
- CRP > 5 mg/L
- Signed informed consent form
Exclusion Criteria:
- Inability to preform total colonoscopy
- Marked abdominal comorbidities
- Prior abdominal surgery
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Device: Thermography
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Procedure: Colonoscopy
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Primary Outcome(s)
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Change in abdominal surface temperatures in ulcerative colitis patients at 6 months
[Time Frame: Six months]
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Secondary Outcome(s)
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Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.
[Time Frame: Baseline and after 6 months]
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Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.
[Time Frame: Baseline and after 6 months]
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Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.
[Time Frame: Baseline and after 6 months]
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Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.
[Time Frame: Baseline and after 6 months]
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Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.
[Time Frame: Baseline and after 6 months]
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Secondary ID(s)
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THERMO-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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