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

October 9, 2024 updated by: Medtronic - MITG

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female adults ages 45-75 years

  2. 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)
  3. Subject is willing and able to participate in study procedures, understand and sign the informed consent

Exclusion Criteria:

  1. Subject has a previous history or suspicion of inflammatory bowel or Crohn's disease, ulcerative Colitis or indeterminant Colitis
  2. Subject has congestive heart failure or recent myocardial infarction (<3month)
  3. Subject with moderate/severe renal disease and/ or severe hepatic impairment
  4. Subject has uncontrolled diabetes
  5. Subject has a severe, life-threatening disease
  6. Subject with known gastrointestinal motility disorders
  7. Subject has known delayed gastric emptying
  8. Subject has undergone surgery of the luminal gastrointestinal (GI) tract, from esophagus to the rectum, other than uncomplicated appendectomy or cholecystectomy.
  9. 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)
  10. Subject with dysphagia, any swallowing disorder, or any major gastrointestinal motility disorder
  11. Subject has a history of inadequate bowel preparation for colon imaging with colonoscopy, CTC, CCE, or DCBE (self-reporting)
  12. 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
  13. Subject with a cardiac pacemaker or other implanted electromedical device
  14. Subject with planned MRI examination within 7 days after ingestion of the capsule

  15. 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).
  16. Subject has glucose-6-phosphate dehydrogenase (G6PD) deficiency and/or allergic to peanut/soya
  17. Subject consumes any of the medicinal products which interacts with MB-MMX, as per MB-MMX label and Investigator's discretion.
  18. 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.
  19. Subject use of opioid medication on a regular basis and requires medication to treat opioid induced constipation
  20. Subject currently participating in another gastrointestinal clinical study (investigational drug or device) that might interfere with results of study
  21. Females who are pregnant or breastfeeding at time of bowel prep
  22. Any condition which precludes compliance with study and/or device instructions based on the clinical judgment of the investigator
  23. Subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
  24. Medtronic employees

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PillCam Colon2 procedure with MB-MMX
Device: PillCam Colon2 procedure with MB-MMX
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE)
Time Frame: During the CCE procedure
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.
Time Frame: 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. 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)
Time Frame: During CCE
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)
During CCE

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Evaluate the Safety of CCE Procedure While Using MB-MMX.
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT20062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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