Inflammatory Bowel Diseases Clinical Trial
Official title:
A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract
NCT number | NCT04085211 |
Other study ID # | KCH19-069 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | May 2022 |
This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract. This study aims to determine: (i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions (ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment
Status | Recruiting |
Enrollment | 260 |
Est. completion date | May 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age > 18 years old - Patient has mental capacity to consent - Requires endoscopic procedure as part of routine care Exclusion Criteria: - not meeting inclusion criteria |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Gastroenterology, King's College Hospital | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions | Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing | 8 weeks | |
Secondary | Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease. | Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy. | 12 months | |
Secondary | median duration for image enhanced endoscopy procedures | median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope | 1 day |
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