Trial Outcomes & Findings for Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX (NCT NCT05022719)
NCT ID: NCT05022719
Last Updated: 2024-10-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
During the CCE procedure
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG 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).
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PillCam Colon2 Procedure With Methylene Blue (MB-MMX) - PEG 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).
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|---|---|---|
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Overall Study
STARTED
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5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
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0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PillCam Colon2 With Methylene Blue (MB-MMX) Split Dose
n=5 Participants
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)
|
PillCam Colon2 With Methylene Blue Single Dose
n=3 Participants
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)
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Total
n=8 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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65.6 years
n=5 Participants
|
58.3 years
n=3 Participants
|
62.9 years
n=8 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
3 participants
n=3 Participants
|
8 participants
n=8 Participants
|
|
BMI
|
27.3 kg/m^2
n=5 Participants
|
26.6 kg/m^2
n=3 Participants
|
27.1 kg/m^2
n=8 Participants
|
PRIMARY outcome
Timeframe: During the CCE procedurePopulation: All subjects were included in the Per Protocol Analysis (N=8); 30 total polyps were visualized across the 8 patients.
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
Outcome measures
| Measure |
PillCam Colon2 Procedure With MB-MMX Split Dose
n=24 # of Polyps
PillCam 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.
|
PillCam Colon2 Procedure With MB-MMX Single Dose
n=6 # of Polyps
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.
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|---|---|---|
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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
Interval 36.6 to 77.9
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66.7 percentage of polyps with contrast
Interval 22.3 to 95.7
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The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE)
% Cecum Polyps
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0 percentage of polyps with contrast
Interval 0.0 to 0.0
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0 percentage of polyps with contrast
Interval 0.0 to 0.0
|
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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
Interval 29.2 to 100.0
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0 percentage of polyps with contrast
Interval 0.0 to 0.0
|
|
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
Interval 1.3 to 98.7
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100 percentage of polyps with contrast
Interval 100.0 to 100.0
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The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE)
% Descending Polyps
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66.7 percentage of polyps with contrast
Interval 9.4 to 99.2
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100 percentage of polyps with contrast
Interval 100.0 to 100.0
|
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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
Interval 24.7 to 75.4
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66.7 percentage of polyps with contrast
Interval 9.4 to 99.2
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PRIMARY outcome
Timeframe: During CCEPopulation: All subjects were included in the per protocol analysis set.
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.
Outcome measures
| Measure |
PillCam Colon2 Procedure With MB-MMX Split Dose
n=5 Participants
PillCam 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.
|
PillCam Colon2 Procedure With MB-MMX Single Dose
n=3 Participants
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.
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|---|---|---|
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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
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1.2 score on a scale of 1 to 5
Standard Deviation 0.4
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4.8 score on a scale of 1 to 5
Standard Deviation 1
|
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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
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1.2 score on a scale of 1 to 5
Standard Deviation 0.4
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3.3 score on a scale of 1 to 5
Standard Deviation 1.2
|
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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
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1.2 score on a scale of 1 to 5
Standard Deviation 0.4
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1.7 score on a scale of 1 to 5
Standard Deviation 0.6
|
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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
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1.3 score on a scale of 1 to 5
Standard Deviation 0.6
|
|
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
|
1 score on a scale of 1 to 5
Standard Deviation 0
|
|
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
|
1.7 score on a scale of 1 to 5
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: During CCEPopulation: All subjects were included in the Per Protocol Analysis (N=8)
Count of Subjects with Polyps visualized during Colon Capsule Endoscopy (CCE)
Outcome measures
| Measure |
PillCam Colon2 Procedure With MB-MMX Split Dose
n=5 Participants
PillCam 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.
|
PillCam Colon2 Procedure With MB-MMX Single Dose
n=3 Participants
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.
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|---|---|---|
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Subjects With Polyps Visualized During Colon Capsule Endoscopy (CCE)
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4 Participants
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2 Participants
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SECONDARY outcome
Timeframe: 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.
All AEs will be reported by number, type, relatedness (device/procedure), seriousness, severity and duration. All AEs will be captured, regardless of severity.
Outcome measures
| Measure |
PillCam Colon2 Procedure With MB-MMX Split Dose
n=5 Participants
PillCam 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.
|
PillCam Colon2 Procedure With MB-MMX Single Dose
n=3 Participants
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.
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|---|---|---|
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To Evaluate the Safety of CCE Procedure While Using MB-MMX.
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0 Events
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0 Events
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Adverse Events
PillCam Colon2 Procedure With MB-MMX Split Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PillCam Colon2 Procedure With MB-MMX Single Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place