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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Methylene blue, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Not applicable
Enrollment
8 participants (actual)
Sponsor
Medtronic - MITG · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Spain

Start
4 Oct 2021
Primary completion
28 Sept 2022
Completion
28 Sept 2022
First posted
26 Aug 2021
Last update posted
15 Oct 2024
Conditions
Colorectal Cancer · Polyp, Colonic

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. N/A

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

    NCT05022719

    4 Oct 2021 to 28 Sept 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PillCam Colon2 procedure with MB-MMXDevice

Arms1

  • Experimental

    PillCam Colon2 procedure with MB-MMX

    PillCam Colon2 procedure with MB-MMX

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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

  2. 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

    Registry description

    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.

  3. Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)

    Time frame · During CCE

    Registry description

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

Secondary outcomes(1)
  1. 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).

    Registry description

    All AEs will be reported by number, type, relatedness (device/procedure), seriousness, severity and duration. All AEs will be captured, regardless of severity.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· During the CCE procedure

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

GroupValue (percentage of polyps with contrast)
PillCam Colon2 Procedure With MB-MMX Split Dose58.3
PillCam Colon2 Procedure With MB-MMX Single Dose66.7
Primary outcomeMean· During CCE

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.

GroupValue (score on a scale of 1 to 5)Spread
PillCam Colon2 Procedure With MB-MMX Split Dose1.20.4
PillCam Colon2 Procedure With MB-MMX Single Dose4.81
Primary outcomeCount of participants· During CCE

Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)

GroupValue (Participants)
PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Split Dose4
PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Single Dose2
Secondary and other outcome results(1)
Secondary outcomeNumber· 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).

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

GroupValue (Events)
PillCam Colon2 Procedure With MB-MMX Split Dose0
PillCam Colon2 Procedure With MB-MMX Single Dose0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PillCam Colon2 Procedure With MB-MMX Split DosePillCam Colon2 procedure with MB-MMX: Subjects will undergo a bowel preparation (split 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.0 / 50 / 50 / 5
PillCam Colon2 Procedure With MB-MMX Single DosePillCam 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.0 / 30 / 30 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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