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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pure-Vu EVS | Other | 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:
The lower bound will be compared to a 35% performance goal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure-Vu EVS | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incomplete colonoscopies | 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:
The lower bound will be compared to a 35% performance goal. | Day 0 (Procedure Day) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Screening | The following secondary endpoint will be assessed: Number of polyps and adenomas: type, location, size, pathology and morphology | Day 0 (Procedure Day) |
| Assessment of Screening |
| Measure | Description | Time Frame |
|---|---|---|
| User Satisfaction | Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure. | Day 0(Procedure Day) |
| Comparison Rates | Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pomeranz | Motus GI Medical Technologies Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU | New York | New York | 02241 | United States |
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| Label | URL |
|---|---|
| More information about Pure-VU® EVS | View source |
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Information regarding the study and study data will be made available via publication on clinicaltrials.gov.
Upon completion of the study.
clinicaltrials.gov
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2022 | Nov 15, 2022 | Prot_001.pdf |
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Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial
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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.
| Day 0 (Procedure Day) |
| Procedural Outcome | Sedation type The type of sedation will not be dictated by the study but will be documented. | Day 0 (Procedure Day) |
| Procedural Outcome | Cecum Intubation Rate | Day 0 (Procedure Day) |
| Assessment screening | Polyp Miss Rate (PMR) | Day 0 (Procedure Day) |
| Assessment screening | Adenoma Detection Rate (ADR) | Day 0 (Procedure Day) |
| Assessment screening | Adenoma Miss Rate (AMR) | Day 0 (Procedure Day) |
| Assessment screening | Adenoma Per Colonoscopy (APC) | Day 0 (Procedure Day) |
| Assessment screening | Adenomas Per Positive Patient (APP) | Day 0 (Procedure Day) |
| Assessment screening | Sessile Serrated Adenoma Detection Rate | Day 0 (Procedure Day) |
| Assessment Screening | Polyp Detection Rate (PDR) | Day 0 (Procedure Day) |
| Procedural Outcomes | Procedure Time: Time to cecum and withdrawal time | Day 0 (Procedure Day) |
| Procedural Outcomes | Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented. | Day 0 (Procedure Day) |
| Day 0 (Procedure Day) - 1-14 day follow up |
| Economic Impact | 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. | Through study completion, an average of 1 year. |