Colorectal Cancer (CRC) Screening
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 study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS). Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
Interventions
DEVICECleanC system
Cleansing liquid and fecal matter during a standard colonoscopy procedure
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 in the age range of 18-75 years 2. Subjects with BMI within the range of 18.5-35 3. Subject is willing to sign informed consent form
Exclusion criteria
1. Active or severe inflammatory bowel disease (IBD) 2. Subjects with severe diverticulitis \\ diverticular disease (known or detected) 3. Known or detected colonic stenosis 4. Known or detected bowel obstruction 5. History of prior colon surgery 6. ASA≥IV (sever systemic disease) 7. Sever Renal insufficiency (Creatinine≥1.5mg%) 8. Sever Liver insufficiency (ALT/AST≥2UNL) 9. Contraindication for colonoscopy anesthesia \\ sedation \\ prep agent 10. pregnancy 11. Subjects with altered mental status/inability to provide informed consent 12. Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | During the colonoscopy procedure withdrawal phase (10 min in average) | Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy. |
| Safety as Measured by Number of Serious Adverse Events and Major Complications. | Max of 9 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Whom the Cecum Was Reached | During the colonoscopy procedure | A procedure was considered complete when the cecum was reached and visualized. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CleanC Standard colonoscopy procedure using the CleanC system
CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | CleanC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 52.3 years STANDARD_DEVIATION 13 |
| Region of Enrollment Israel | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.
Time frame: During the colonoscopy procedure withdrawal phase (10 min in average)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CleanC | Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | 88.9 percentage of participants |
Primary
Safety as Measured by Number of Serious Adverse Events and Major Complications.
Time frame: Max of 9 days
Secondary
Percentage of Participants in Whom the Cecum Was Reached
A procedure was considered complete when the cecum was reached and visualized.
Time frame: During the colonoscopy procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CleanC | Percentage of Participants in Whom the Cecum Was Reached | 88.9 percentage of participants |