CRC
Conditions
Brief summary
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.
Detailed description
The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy
Interventions
DEVICEMotus Cleansing System
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects being considered for diagnostic, screening or surveillance colonoscopy 2. Subjects in the age range of 18-75 years inclusive 3. Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive 4. Subject has signed the informed consent
Exclusion criteria
1. Subjects with known Inflammatory Bowel Disease 2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease 3. Subjects with known or detected (during colonoscopy) bowel obstruction 4. History of prior surgery to colon and/or rectum 5. ASA≥IV 6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history) 7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history) 8. Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy 9. Pregnancy (as stated by patient) or breast feeding 10. Subjects with altered mental status/inability to provide informed consent 11. Patients who have participated in another interventional clinical study in the last 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS | Within 24 hours- During the colonoscopy procedure | The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS\>1 in all colon segments |
Countries
Israel
Participant flow
Recruitment details
all patients recruited between Feb 2016 to Dec 2016 at Emek Medical Center, Afula Israel.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Motus Cleansing System | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Motus Cleansing System (MCS) |
|---|---|
| Age, Continuous | 46.5 YEARS STANDARD_DEVIATION 13.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS
The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS\>1 in all colon segments
Time frame: Within 24 hours- During the colonoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motus Cleansing System (MCS) | Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS | 9 Participants |
Comparison: patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.95% CI: [66, 100]