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Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.
The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.
63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.
40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with MotusGi CleanUp System Rev 1.0 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 |
| |
| Colonoscopy with MotusGi CleanUp System Rev 1.5 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motus Gl CleanUp System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System | Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System | during colonoscopy procedure after cleansing with CleanUp System |
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Inclusion Criteria:
Exclusion Criteria:
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subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica San Rafael | Cadiz | 11002 | Spain |
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The recruitment was done in two phases:
Phase 1- under protocol Rev 1.0 used MotusGi CleanUp System Rev 1.0 , study period Aug- Jan 2012. 40 subjects enrolled.
Phase 2- under protocol Rev 2.0 used MotusGi CleanUp System Rev 1.5 , study period Jul-Oct 2013.31 subjects enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonoscopy With MotusGi CleanUp System Rev 1.0 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System |
| FG001 | Colonoscopy With MotusGi CleanUp System Rev 1.5 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonoscopy With MotusGi CleanUp System Rev 1.0 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System |
| BG001 | Colonoscopy With MotusGi CleanUp System Rev 1.5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System | Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System | the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System | Posted | Mean | Standard Deviation | units on a scale | during colonoscopy procedure after cleansing with CleanUp System |
|
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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 | Colonoscopy With MotusGi CleanUp System Rev 1.0 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erosion | Gastrointestinal disorders | Systematic Assessment | mild erosion probably related to colonoscopy procedure resolved without clinical intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravit Peled -Director of Clinical Trial | MotusGI | +972 (0)4 6214447 | 203 | ravit@motusgi.com |
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subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 17 |
| 40 |
| EG001 | Colonoscopy With MotusGi CleanUp System Rev 1.5 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System | 0 | 31 | 0 | 31 | 17 | 31 |
|
| Hematoma | Gastrointestinal disorders | Systematic Assessment | mild Hematoma resolved without clinical intervention |
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| Vesicles | Gastrointestinal disorders | Systematic Assessment | mild |
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| Laceration | Gastrointestinal disorders | Systematic Assessment | 5 mild and 1 moderate lacerations resolved without clinical intervention |
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| Papules | Gastrointestinal disorders | Systematic Assessment | mild Papules resolved without clinical intervention |
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