Colorectal Cancer, Gastrointestinal Disease
Conditions
Keywords
bowel prepartion
Brief summary
The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
Detailed description
This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure. Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation. Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system. In case of inadequate bowel preparation, as per the nurse report and / or BBPS \< 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu. Follow-up will be conducted at 48 hours (± 48 hours) post procedure.
Interventions
DEVICEPure-Vu System
The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy 2. Patients' age \> 22 years 3. Patient has signed the informed consent
Exclusion criteria
1. Patients with known Inflammatory Bowel Disease and / or active Colitis 2. Patients with active diverticulitis 3. Patients with known or detected (during colonoscopy) bowel obstruction 4. Patients with BMI ≤ 18 5. Patients with ascites Child Pugh C 6. Patients who are 30 days post-transplant 7. Patients treated with Peritoneal dialysis 8. Patients under active IV inotropic medications 9. Patients with LVAD 10. Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician) 11. Subjects with known coagulation disorder (INR ≥ 2 or platelets \<50,000) 12. Subjects with hemodynamic instability. 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 |
|---|---|---|
| The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System | up to 2 hours | The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colonoscopy With Pure-Vu System Inpatient colonoscopies with Pure-Vu System- Single Arm
Pure-Vu System: The Pure-Vu System is FDA cleared device intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood. | 94 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not meet eligibility | 1 |
Baseline characteristics
| Characteristic | Colonoscopy With Pure-Vu System | — |
|---|---|---|
| Age, Customized | 62.44 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 25 participants | — |
| Region of Enrollment United States | 69 participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 94 |
| other Total, other adverse events | 3 / 94 |
| serious Total, serious adverse events | 1 / 94 |
Outcome results
Primary
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.
Time frame: up to 2 hours
Population: Rate of Adequacy of bowel preparation using the Boston Bowel Preparation Score (BBPS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Colonoscopy With Pure-Vu System | The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System | Rate of adequate preparation measured by BBPS before Pure-Vu Use | 38 Percentage of Adequate cleansing |
| Colonoscopy With Pure-Vu System | The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System | Rate of adequate preparation measured by BBPS after Pure-Vu Use | 96 Percentage of Adequate cleansing |