Colorectal Cancer, Polyp, Colonic
Conditions
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.
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.
Interventions
DEVICEPillCam 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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | 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. | 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) | During CCE | Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | All AEs will be reported by number, type, relatedness (device/procedure), seriousness, severity and duration. All AEs will be captured, regardless of severity. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PillCam Colon2 With Methylene Blue (MB-MMX) Split Dose 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) as bowel preparation for PillCam Colon2 Capsule Endoscopy (CCE) | 5 |
| PillCam Colon2 With Methylene Blue Single Dose 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) as bowel preparation for PillCam Colon2 Capsule Endoscopy (CCE) | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | PillCam Colon2 With Methylene Blue (MB-MMX) Split Dose | PillCam Colon2 With Methylene Blue Single Dose | Total |
|---|---|---|---|
| Age, Continuous | 65.6 years | 58.3 years | 62.9 years |
| BMI | 27.3 kg/m^2 | 26.6 kg/m^2 | 27.1 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)
Time frame: During CCE
Population: All subjects were included in the Per Protocol Analysis (N=8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillCam Colon2 Procedure With MB-MMX Split Dose | Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE) | 4 Participants |
| PillCam Colon2 Procedure With MB-MMX Single Dose | Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE) | 2 Participants |
Primary
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.
Time frame: During CCE
Population: All subjects were included in the per protocol analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | Transverse | 1.2 score on a scale of 1 to 5 | Standard Deviation 0.4 |
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | Rectum | 1 score on a scale of 1 to 5 | Standard Deviation 0 |
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | All Segments | 1.2 score on a scale of 1 to 5 | Standard Deviation 0.4 |
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | Cecum | 1.2 score on a scale of 1 to 5 | Standard Deviation 0.4 |
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | Descending | 1.3 score on a scale of 1 to 5 | Standard Deviation 0.5 |
| PillCam Colon2 Procedure With MB-MMX Split Dose | 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. | Ascending | 1.2 score on a scale of 1 to 5 | Standard Deviation 0.4 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | Rectum | 1.7 score on a scale of 1 to 5 | Standard Deviation 0.6 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | Cecum | 3.3 score on a scale of 1 to 5 | Standard Deviation 1.2 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | Ascending | 1.7 score on a scale of 1 to 5 | Standard Deviation 0.6 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | Transverse | 1.3 score on a scale of 1 to 5 | Standard Deviation 0.6 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | Descending | 1 score on a scale of 1 to 5 | Standard Deviation 0 |
| PillCam Colon2 Procedure With MB-MMX Single Dose | 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. | All Segments | 4.8 score on a scale of 1 to 5 | Standard Deviation 1 |
Primary
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
Time frame: During the CCE procedure
Population: All subjects were included in the Per Protocol Analysis (N=8); 30 total polyps were visualized across the 8 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Transverse Polyps | 50 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Ascending Polyps | 100 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Descending Polyps | 66.7 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Cecum Polyps | 0 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Rectal Polyps | 50 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Split Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | Overall % Polyps with Contrast | 58.3 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Rectal Polyps | 66.7 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Ascending Polyps | 0 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Transverse Polyps | 100 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | Overall % Polyps with Contrast | 66.7 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Cecum Polyps | 0 percentage of polyps with contrast |
| PillCam Colon2 Procedure With MB-MMX Single Dose | The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) | % Descending Polyps | 100 percentage of polyps with contrast |
Secondary
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.
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).
Population: All enrolled subjects were included in the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam Colon2 Procedure With MB-MMX Split Dose | To Evaluate the Safety of CCE Procedure While Using MB-MMX. | 0 Events |
| PillCam Colon2 Procedure With MB-MMX Single Dose | To Evaluate the Safety of CCE Procedure While Using MB-MMX. | 0 Events |