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Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX

Colorectal Cancer Clinical Trial

Official title:
A Prospective Single-center Pilot Study Evaluating the Technical Feasibility of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX (SPICE Study)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05022719
Study type Interventional
Source Medtronic - MITG
Contact
Status Completed
Phase N/A
Start date October 4, 2021
Completion date September 28, 2022
View Details
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