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

NCT05022719 | Completed Results

• 1 other identifier: MDT20062
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Polyp, Colonic

Outcome Measures

Primary Outcomes (3)

• The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (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

  During the CCE procedure

• The Interference Level of Detrimental Effects on the Visualization of the Colonic Mucosa During Colon Capsule Endoscopy (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.

  During CCE

• Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)

  Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)

  During CCE

Secondary Outcomes (1)

• To Evaluate the Safety of CCE Procedure While Using MB-MMX.

  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).

Study Arms (1)

PillCam Colon2 procedure with MB-MMX

EXPERIMENTAL

PillCam Colon2 procedure with MB-MMX

Device: PillCam Colon2 procedure with MB-MMX

Interventions

PillCam Colon2 procedure with MB-MMX DEVICE

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.

PillCam Colon2 procedure with MB-MMX

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melanie Crystal
• Organization: Medtronic

melanie.crystal@medtronic.com

774-245-8756

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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: 1. The percent of colonic polyps which have a visible contrast to the healthy colonic mucosa during CCE. 2. The interference level of detrimental effects on the visualization of the colonic mucosa during CCE, due to use of MB-MMX per colonic segment.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 26, 2021
• Study Start: October 4, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-04

Locations

ES (1)