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The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).
Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CleanC | Experimental | Standard colonoscopy procedure using the CleanC system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CleanC system | Device | Cleansing liquid and fecal matter during a standard colonoscopy procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
| During the colonoscopy procedure withdrawal phase (10 min in average) |
| Safety as Measured by Number of Serious Adverse Events and Major Complications. | Max of 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Whom the Cecum Was Reached | A procedure was considered complete when the cecum was reached and visualized. | During the colonoscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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De-identified individual participant for primary and secondary outcome measures may be become available in the future
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| ID | Title | Description |
|---|---|---|
| FG000 | CleanC | Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CleanC | Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
| Posted | Number | 95% Confidence Interval | percentage of participants | During the colonoscopy procedure withdrawal phase (10 min in average) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CleanC | Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Mild abdominal pain was reports as probably related to colonoscopy procedure and not to Motus GI CleanC system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Kobie Dickstein | M.C.Carmel | 048250055 | kobiedi@clalit.org.il |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
|
|
| Primary | Safety as Measured by Number of Serious Adverse Events and Major Complications. | Not Posted | Max of 9 days | Participants |
| Secondary | Percentage of Participants in Whom the Cecum Was Reached | A procedure was considered complete when the cecum was reached and visualized. | Posted | Number | 95% Confidence Interval | percentage of participants | During the colonoscopy procedure |
|
|
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| 0 |
| 10 |
| 1 |
| 10 |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |