Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05022719
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2021-08-12
Brief Title:
Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy CCE Procedure in Colorectal Cancer CRC High Risk Population When Using MB-MMX
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Up to 15 subjects will be enrolled in 1 center located in Spain Study duration- up to 10 months from study approval
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None