CRC
Conditions
Keywords
Colonoscopy Cleaning
Brief summary
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.
Interventions
DEVICEMotus GI Clean-Up Device
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects in the age range of 50-69 years 2. Subjects who are considered for routine screening colonoscopy 3. Subjects with BMI within the range of 18.5-30 4. Subject is willing to sign informed consent form
Exclusion criteria
1. History of GI diseases or history of Colorectal cancer (personal or family) 2. Previous major abdominal surgeries 3. Medical status ASA grater or equal to 3 4. Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD). 5. Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel) 6. Life-threatening condition 7. Subjects who are unable or unwilling to cooperate with study procedures 8. Severe Diverticula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of All Subjects Colon Segments BBPS>=2 | Following the colonoscopic procedure- Up to 24 hours. | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colonoscopy Motus GI Clean-Up Device | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Colonoscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Gender Female | 8 Participants |
| Gender Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Following the colonoscopic procedure- Up to 24 hours.
Population: 15 subjects were enrolled to the study.~1 was excluded. Total of 14 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colonoscopy | Mean of All Subjects Colon Segments BBPS>=2 | 3 Mean of BBPS score per segment | Standard Deviation 0 |