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The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.
Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).
Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with MCS | Experimental | Standard colonoscopy procedure with Motus Cleansing System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motus Cleansing System (MCS) | Device | The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of MCS in Cleansing a Poorly Prepared Colon. | The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation. | Up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravit Peled | Motus GI Technologies Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZ | Mainz | Germany | ||||
| University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29996152 | Derived | van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11. |
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The patients had reduced preparation in order to mimic poor bowel cleansing. the study bowel preparation consisted of dietary restrictions (no dried fruit, seeds or nuts) starting 2 days prior to colonoscopy, a 24-hour clear liquid diet and a split dose of 20 mg Bisacodyl (10 mg in each dose).
patients indicated for screening/ surveillance or diagnosis colonoscopy enrolled at 3 clinical sites as follows:
enrollment period : 20 December 2016 - 31 May 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonoscopy With MCS | Standard colonoscopy procedure with Motus Cleansing System Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonoscopy With MCS | Standard colonoscopy procedure with Motus Cleansing System Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. |
| 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 | Performance of MCS in Cleansing a Poorly Prepared Colon. | The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation. | the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent) | Posted | Count of Participants | Participants | Up to 2 hours |
|
Follow up was conducted immediately after the procedure before patient discharge and at 2-3 days and 14-16 days post procedure
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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 MCS | Standard colonoscopy procedure with Motus Cleansing System Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Systematic Assessment | abdominal discomfort and or stomach discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravit Peled -Director of Clinical Trial | Motus GI Medical Technologies Ltd. | 0733243823 | 203 | ravit@motusgi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2016 | Dec 13, 2017 | Prot_SAP_000.pdf |
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|
| Nijmegen |
| Netherlands |
| Erasmus medical center | Rotterdam | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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|
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| 0 |
| 47 |
| 0 |
| 47 |
| 5 |
| 47 |
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