CRC
Conditions
Brief summary
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.
Detailed description
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: 1. One head that irrigates and evacuates instead of two heads 2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate. 3. System adjustment to the above changes including updated software version.
Interventions
DEVICEMotus Gl CleanUp System
Sponsors
Motus GI Medical Technologies Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects in the age range of 50-69 years * Subjects who are considered for routine screening colonoscopy * Subjects with BMI within the range of 18.5-30 * Subject is willing to sign informed consent form
Exclusion criteria
* History of G diseases or history of Colorectal cancer (personal or family) * Previous major abdominal surgeries * Medical status ASA grater or equal to 3 * Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD). * Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel) * Life-threatening condition * Subjects who are unable or unwilling to cooperate with study procedures * Severe Diverticula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System | during colonoscopy procedure after cleansing with 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 |
Countries
Spain
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 29 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 6 | 2 |
Baseline characteristics
| Characteristic | Colonoscopy With MotusGi CleanUp System Rev 1.0 | Colonoscopy With MotusGi CleanUp System Rev 1.5 | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 3.8 | 53 years STANDARD_DEVIATION 4.1 | 54 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 31 |
| other Total, other adverse events | 17 / 40 | 17 / 31 |
| serious Total, serious adverse events | 0 / 40 | 0 / 31 |
Outcome results
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
Time frame: during colonoscopy procedure after cleansing with CleanUp System
Population: the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colonoscopy With MotusGi CleanUp System Rev 1.0 | Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System | 2.9 units on a scale | Standard Deviation 0.4 |
| Colonoscopy With MotusGi CleanUp System Rev 1.5 | Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System | 2.9 units on a scale | Standard Deviation 0.2 |