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Motus GI 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motus GI Clean-Up Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of All Subjects Colon Segments BBPS>=2 | Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2. | Following the colonoscopic procedure- Up to 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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De-identified individual participant data for all primary and secondary outcome measures may be made available in the future
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonoscopy | Motus GI Clean-Up Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonoscopy | Motus GI Clean-Up Device |
| 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 | Mean of All Subjects Colon Segments BBPS>=2 | Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2. | 15 subjects were enrolled to the study. 1 was excluded. Total of 14 subjects were analyzed. | Posted | Mean | Standard Deviation | Mean of BBPS score per segment | Following the colonoscopic procedure- Up to 24 hours. |
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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 | Motus GI Clean-Up Device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Abdominal bloating | Gastrointestinal disorders | Non-systematic Assessment | Post procedure AE as seen in a standard colonoscopy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Consultant | Motus GI Medical Technologies Ltd. | +972-4-6214446 | 104 | rose@motusgi.com |
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| Participants |
|
| Gender | Count of Participants | Participants |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
|
| Mild mucosal bruising | Gastrointestinal disorders | Non-systematic Assessment | Only mild mucosal bruising as seen in a standard colonoscopy. |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment | Mild, unrelated Bradycardia due to sedation. |
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