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

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.

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