A prospective, single-center, single-arm, non-randomized, post-market pilot study evaluating the technical feasibility of mucosal staining during COLON2 Capsule Endoscopy (CCE) procedure in population at high risk for Colorectal Cancer (CRC), when using MB-MMX (Methylene Blue). Up to 15 subjects will be enrolled in 1 center located in Spain. Study duration- up to 10 months from study approval.
Single-center, prospective, non-randomized clinical trial designed to evaluate the technical feasibility during CCE procedure, when using MB-MMX as a contrast- enhancement technique of mucosal staining in CRC high risk population. Subjects will undergo a bowel preparation (single dose, 4L PEG), including 200 mg Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets and 1 tab of Resolor (Prucalopride 1mg). An experienced Gastroenterologist will read the CCE procedure and complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure, when using MB-MMX as a contrast-enhancement technique.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
8
Subjects will undergo a bowel preparation (single dose, 4L PEG), including 200 mg Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets and 1 tab of Resolor (Prucalopride 1mg). An experienced Gastroenterologist will read the CCE procedure and complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure, when using MB-MMX as a contrast-enhancement technique.
Complejo Hospitalario de Navarra
Pamplona, Spain
The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE)
The percent of colonic polyps which have a visible contrast to the healthy colonic mucosa during CCE, as indicated by an experienced reader, using the subjective reader questionnaire (For each polyp - was there a contrast between the polyp and the healthy mucosa? Yes/No), out of the examined polyps
Time frame: During the CCE procedure
The Interference Level of Detrimental Effects on the Visualization of the Colonic Mucosa During Colon Capsule Endoscopy (CCE), Due to Use of MB-MMX Per Colonic Segment.
The interference level of detrimental effects on the visualization of the colonic mucosa during CCE, due to use of MB-MMX per colonic segment. Detrimental effect will be considered as any observation, such as an excessive blue dye deposit, dark and dim appearance of the tissue, interfering with tissue visualization and will be evaluated on a scale from 1 (no interference) to 5 (high interference) to evaluate the level of interference, using a subjective reader questionnaire.
Time frame: During CCE
Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)
Time frame: During CCE
To Evaluate the Safety of CCE Procedure While Using MB-MMX.
All AEs will be reported by number, type, relatedness (device/procedure), seriousness, severity and duration. All AEs will be captured, regardless of severity.
Time frame: Evaluated for each patient enrolled from day -1 prior to the procedure (start of bowel prep intake) until day 5-9 after the procedure (end of follow-up).
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