Colorectal CancerNCT05022719

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

A study testing PillCam Colon2 procedure with MB-MMX in people with Colorectal Cancer and Polyp, Colonic, run by Medtronic - MITG at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Colorectal Cancer, Polyp, Colonic
What is being tested?: PillCam Colon2 procedure with MB-MMX
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteSpain
Study dates: 4 Oct 2021to 28 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 26Show fewer

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Complejo Hospitalario de Navarra
Pamplona, 31008

Other trials in Spain

About this study

Official title: 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)

Up to 15 subjects will be enrolled in 1 center located in Spain. Study duration- up to 10 months from study approval.

Read the 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.

Conditions: Colorectal Cancer, Polyp, Colonic
Being tested: PillCam Colon2 procedure with MB-MMX
Medical subject headings: Colorectal Neoplasms, Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PillCam Colon2 procedure with MB-MMXDevice
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 groups in NCT05022719
Study group	Role	What they receive
PillCam Colon2 procedure with MB-MMX	Experimental	PillCam Colon2 procedure with MB-MMX Receives: Device: PillCam Colon2 procedure with MB-MMX

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: During CCE
Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)
Measured: During CCE

Secondary outcomes (1)

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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202128 Sep 2022

First posted26 Aug 2021
Study start4 Oct 2021
Primary completion28 Sep 2022
Study completion28 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
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: 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.
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05022719
Sponsor's protocol ID: MDT20062
Status last verified: Apr 2024
First submitted: 12 Aug 2021
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05022719
Acronym / sponsor ID: MDT20062
Conditions: Colorectal Cancer, Polyp, Colonic
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 4 Oct 2021 (actual)
Primary completion: 28 Sep 2022 (actual)
Study completion: 28 Sep 2022 (actual)
First posted: 26 Aug 2021 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Up to 15 subjects will be enrolled in 1 center located in Spain. Study duration- up to 10 months from study approval.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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: 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.

Arm	Type	Receives
PillCam Colon2 procedure with MB-MMX	Experimental	Device: PillCam Colon2 procedure with MB-MMXPillCam Colon2 procedure with MB-MMX

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Subject is willing and able to participate in study procedures, understand and sign the informed consent

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PillCam Colon2 procedure with MB-MMXSubjects 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.	Device	PillCam Colon2 procedure with MB-MMX

Primary outcome

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
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.
Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)
Time frame: During CCE
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)

1 secondary outcome

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).

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Split Dose	5	5
PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Single Dose	3	3

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage of polyps with contrast

Measure	PillCam Colon2 Procedure With MB-MMX Split Dose n = 5	PillCam Colon2 Procedure With MB-MMX Single Dose n = 3
Overall % Polyps with Contrast	58.3 (36.6 to 77.9)	66.7 (22.3 to 95.7)
% Cecum Polyps	0 (0 to 0)	0 (0 to 0)
% Ascending Polyps	100 (29.2 to 100)	0 (0 to 0)
% Transverse Polyps	50 (1.3 to 98.7)	100 (100 to 100)
% Descending Polyps	66.7 (9.4 to 99.2)	100 (100 to 100)
% Rectal Polyps	50 (24.7 to 75.4)	66.7 (9.4 to 99.2)

Population analysed: All subjects were included in the Per Protocol Analysis (N=8); 30 total polyps were visualized across the 8 patients.

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale of 1 to 5

Measure	PillCam Colon2 Procedure With MB-MMX Split Dose n = 5	PillCam Colon2 Procedure With MB-MMX Single Dose n = 3
All Segments	1.2 (0.4)	4.8 (1)
Cecum	1.2 (0.4)	3.3 (1.2)
Ascending	1.2 (0.4)	1.7 (0.6)
Transverse	1.2 (0.4)	1.3 (0.6)
Descending	1.3 (0.5)	1 (0)
Rectum	1 (0)	1.7 (0.6)

Population analysed: All subjects were included in the per protocol analysis set.

Primary outcome: Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)

Time frame: During CCE. Count of participants. Unit: Participants

Measure	PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Split Dose n = 5	PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG Single Dose n = 3
Value	4	2

Population analysed: All subjects were included in the Per Protocol Analysis (N=8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events will be collected for all enrolled subjects at the start of the bowel preparation, at day (-1), until the follow-up phone call (visit 3). Medical care will be provided, as defined in the informed consent, for any AE related to study participation, if needed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PillCam Colon2 Procedure With MB-MMX Split Dose	0 of 5 (0%)	0 of 5 (0%)	0 of 5
PillCam Colon2 Procedure With MB-MMX Single Dose	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PillCam Colon2 procedure with MB-MMX in people with Colorectal Cancer and Polyp, Colonic, run by Medtronic - MITG at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.