NCT01914445UnknownNot Applicable
Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Efficacy of Indigo Carmine during oral administration
Study Overview
Brief Summary
The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients suffering from Inflammatory Bowel Disease
- •Patients under surveillance for Disease-Associated Lesions and Masses (DALM)
Exclusion Criteria
- •All others
Arms & Interventions
Indigo Carmine
Experimental
Indigo Carmine (2 mg per kilo) and 2nd half of PEG dose will be orally administered to patients prior to colonoscopy.
Intervention: Indigo Carmine (Drug)
Outcomes
Primary Outcomes
Efficacy of Indigo Carmine during oral administration
Time Frame: One hour
The efficacy of Indigo Carmine in staining tissues to better characterize, delineate, and highlight the gastrointestinal mucosa will be determined during the colonoscopic examination. Biopsies will be taken from suspicious lesions.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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