Colorectal Screening
Conditions
Brief summary
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.
Detailed description
The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).
Interventions
DEVICEPure-Vu EVS
Subjects will be enrolled until 115 inadequate bowel prep cases via SOC are accrued and subsequently treated with Pure-Vu EVS. Inadequate OCs defined as such if any of the following are met: * Boston Bowel Preparation Score (BBPS) \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Eligible adults aged between 40-80 2. Elective outpatient colonoscopy by participating gastroenterologist
Exclusion criteria
1. Not competent to consent 2. Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease 3. History of colonic resection 4. Prior incomplete colonoscopy due to patient anatomy 5. Diverticulitis 6. Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate) 7. Known or suspected colon stricture 8. Hereditary Colorectal Cancer Syndrome 9. Subject is pregnant or suspected pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incomplete colonoscopies | Day 0 (Procedure Day) | Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Outcome | Day 0 (Procedure Day) | Sedation type The type of sedation will not be dictated by the study but will be documented. |
| Assessment screening | Day 0 (Procedure Day) | Polyp Miss Rate (PMR) |
| Assessment Screening | Day 0 (Procedure Day) | Polyp Detection Rate (PDR) |
| Procedural Outcomes | Day 0 (Procedure Day) | Procedure Time: Time to cecum and withdrawal time |
| Assessment of Screening | Day 0 (Procedure Day) | The following secondary endpoint will be assessed: Number of polyps and adenomas: type, location, size, pathology and morphology |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic Impact | Through study completion, an average of 1 year. | Economic Impact: Impact will be calculated by utilizing both data generated as part of the study and data published on the costs associated with outpatient colonoscopies and subsequent findings. |
| Comparison Rates | Day 0 (Procedure Day) - 1-14 day follow up | Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%) |
| User Satisfaction | Day 0(Procedure Day) | Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure. |
Countries
United States
Outcome results
None listed