CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
PillCam Colon2 procedure with MB-MMXdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05022719
NCT05022719N/ACompleted
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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)

Medtronic - MITG·interventional·Posted Aug 26, 2021·Updated Oct 15, 2024

In Brief

A clinical study evaluating PillCam Colon2 procedure with MB-MMX for Colorectal Cancer and Polyp, Colonic. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer, Polyp, Colonic
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 26, 2021
Enrollment StartOct 4, 2021
Primary CompletionSep 28, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.9 years ago

Interventions

PillCam Colon2 procedure with MB-MMXdevice

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.