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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Colorectal Cancer, Polyp, Colonic

Intervention / Treatment
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* Device: PillCam Colon2 procedure with MB-MMX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults ages 45-75 years Subject is classified as being at high risk for CRC due to one (or more) of the following risk factors: A personal history of colorectal polyps A first-degree family history of colorectal cancer Family/personal inherited syndrome (Lynch syndrome, Familial adenomatous polyposis {FAP}, other inherited syndromes linked to colorectal cancer) Subject with currently suspected or diagnosed rectal bleeding, including positive FIT or positive fecal DNA test Subjects under surveillance for CRC (last OC≥1.5 years) Subject is willing and able to participate in study procedures, understand and sign the informed consent Exclusion Criteria: Subject has a previous history or suspicion of inflammatory bowel or Crohn's disease, ulcerative Colitis or indeterminant Colitis Subject has congestive heart failure or recent myocardial infarction (<3month) Subject with moderate/severe renal disease and/ or severe hepatic impairment Subject has uncontrolled diabetes Subject has a severe, life-threatening disease Subject with known gastrointestinal motility disorders Subject has known delayed gastric emptying Subject has undergone surgery of the luminal gastrointestinal (GI) tract, from esophagus to the rectum, other than uncomplicated appendectomy or cholecystectomy. Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction or pseudo-obstruction, stricture, or fistula (symptoms such as severe abdominal pain with accompanying nausea or vomiting) Subject with dysphagia, any swallowing disorder, or any major gastrointestinal motility disorder Subject has a history of inadequate bowel preparation for colon imaging with colonoscopy, CTC, CCE, or DCBE (self-reporting) Subject with known or suspected constipation history as defined by the following: as needing the use of medication (prescription or OTC) for management of constipation, or fewer than 3 BM/week regardless of medication use Subject with a cardiac pacemaker or other implanted electromedical device Subject with planned MRI examination within 7 days after ingestion of the capsule The subject is taking antidepressant medicine or a medicine for psychiatric illness, such as: selective serotonin reuptake inhibitor (SSRI)- as fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram and zimeldine; bupropion, venlafaxine, mirtazapine, clomipramine, buspirone medicines classified as Monamine Oxidase Inhibitors (often used for treating depression). Subject has glucose-6-phosphate dehydrogenase (G6PD) deficiency and/or allergic to peanut/soya Subject consumes any of the medicinal products which interacts with MB-MMX, as per MB-MMX label and Investigator's discretion. Subject with allergies or known contraindication to the device, medications or preparation agents used in the procedure as described in the relevant instructions for use/package inserts. Subject use of opioid medication on a regular basis and requires medication to treat opioid induced constipation Subject currently participating in another gastrointestinal clinical study (investigational drug or device) that might interfere with results of study Females who are pregnant or breastfeeding at time of bowel prep Any condition which precludes compliance with study and/or device instructions based on the clinical judgment of the investigator Subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity) Medtronic employees

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model 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. The technical feasibility will be evaluated by: The percent of colonic polyps which have a visible contrast to the healthy colonic mucosa during CCE. The interference level of detrimental effects on the visualization of the colonic mucosa during CCE, due to use of MB-MMX per colonic segment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PillCam Colon2 procedure with MB-MMX<br>PillCam Colon2 procedure with MB-MMX | Device: PillCam Colon2 procedure with MB-MMX<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of colonic polyps which have a visible contrast to the healthy colonic mucosa during 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 | Evaluated by the procedure reader up to 8 weeks after completion of the CCE procedure | 
| The interference level of detrimental effects on the visualization of the colonic mucosa during 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. | Evaluated by the procedure reader up to 8 weeks after completion of the CCE procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). |