Demonstrating Effective Salvage of Inadequate Colonoscopies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Pure-Vu EVS 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. |
Device: Pure-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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Assessment of Screening [Day 0 (Procedure Day)]
Boston Bowel Prep Score (BBPS) before and after Pure-Vu EVS use. Throughout the procedure, the study endoscopist will be requested to document the pre-cleansing BBPS and post- cleansing BBPS for each colon segment.
- Procedural Outcome [Day 0 (Procedure Day)]
Sedation type The type of sedation will not be dictated by the study but will be documented.
- Procedural Outcome [Day 0 (Procedure Day)]
Cecum Intubation Rate
- Assessment screening [Day 0 (Procedure Day)]
Polyp Miss Rate (PMR)
- Assessment screening [Day 0 (Procedure Day)]
Adenoma Detection Rate (ADR)
- Assessment screening [Day 0 (Procedure Day)]
Adenoma Miss Rate (AMR)
- Assessment screening [Day 0 (Procedure Day)]
Adenoma Per Colonoscopy (APC)
- Assessment screening [Day 0 (Procedure Day)]
Adenomas Per Positive Patient (APP)
- Assessment screening [Day 0 (Procedure Day)]
Sessile Serrated Adenoma Detection Rate
- Assessment Screening [Day 0 (Procedure Day)]
Polyp Detection Rate (PDR)
- Procedural Outcomes [Day 0 (Procedure Day)]
Procedure Time: Time to cecum and withdrawal time
- Procedural Outcomes [Day 0 (Procedure Day)]
Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented.
Other Outcome Measures
- User Satisfaction [Day 0(Procedure Day)]
Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure.
- 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%)
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eligible adults aged between 40-80
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Elective outpatient colonoscopy by participating gastroenterologist
Exclusion Criteria:
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Not competent to consent
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Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
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History of colonic resection
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Prior incomplete colonoscopy due to patient anatomy
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Diverticulitis
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Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
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Known or suspected colon stricture
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Hereditary Colorectal Cancer Syndrome
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Subject is pregnant or suspected pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health Brooklyn | Brooklyn | New York | United States | 11220 |
| 2 | NYU Langone Health | Manhattan | New York | United States | 10016 |
Sponsors and Collaborators
- Motus GI Medical Technologies Ltd
Investigators
- Principal Investigator: Aasma Shaukat, MD, NYU Langone.org
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CL00052