CRC
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEMotus 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.
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 BodyMass 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) or dual antiplatelet therapy 9. Subjects with known coagulation disorder (INR \>1.5). 10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl 11. Subjects with active, ongoing lower GI bleeding with hemodynamic instability. 12. Subjects with known Mega Colon 13. Pregnancy (as stated by patient) or breast feeding 14. Subjects with altered mental status/inability to provide informed consent 15. Patients who have participated in another interventional clinical study in the last 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of MCS in Cleansing a Poorly Prepared Colon. | Up to 2 hours | 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. |
Countries
Germany, Netherlands
Participant flow
Recruitment details
patients indicated for screening/ surveillance or diagnosis colonoscopy enrolled at 3 clinical sites as follows: * Radboud University Medical Center(UMC)- Netherlands-16 cases * Erasmus Medical Center (MC)-Netherlands-16 cases * Mainz University Medical Center(UMC)-Germany- 15 cases enrollment period : 20 December 2016 - 31 May 2017
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Colonoscopy With MCS |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 11.8 |
| Body Mass Index (BMI) | 26.0 kg/m^2 STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 2 Participants |
| Race/Ethnicity, Customized Ethnicity White Non-Hispanic | 44 Participants |
| Region of Enrollment Germany | 15 participants |
| Region of Enrollment Netherlands | 32 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 5 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
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.
Time frame: Up to 2 hours
Population: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Colonoscopy With MCS | Performance of MCS in Cleansing a Poorly Prepared Colon. | adequate cleaning after the use of MCS | 46 Participants |
| Colonoscopy With MCS | Performance of MCS in Cleansing a Poorly Prepared Colon. | adequate cleaning at baseline | 9 Participants |
Comparison: The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)p-value: <0.01McNemar