Demonstrating Effective Salvage of Inadequate Colonoscopies

Colorectal Screening Clinical Trial

Official title:

Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05585879
• Other study ID #: CL00052
• Status: Terminated
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: April 26, 2024

Study information

• Verified date: May 2024
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Screening

Intervention

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

Locations

Country	Name	City	State
United States	NYU	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User Satisfaction	Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure.	Day 0(Procedure Day)
Other	Comparison Rates	Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%)	Day 0 (Procedure Day) - 1-14 day follow up
Other	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.
Primary	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: 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.	Day 0 (Procedure Day)
Secondary	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)
Secondary	Assessment of Screening	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)
Secondary	Procedural Outcome	Sedation type The type of sedation will not be dictated by the study but will be documented.	Day 0 (Procedure Day)
Secondary	Procedural Outcome	Cecum Intubation Rate	Day 0 (Procedure Day)
Secondary	Assessment screening	Polyp Miss Rate (PMR)	Day 0 (Procedure Day)
Secondary	Assessment screening	Adenoma Detection Rate (ADR)	Day 0 (Procedure Day)
Secondary	Assessment screening	Adenoma Miss Rate (AMR)	Day 0 (Procedure Day)
Secondary	Assessment screening	Adenoma Per Colonoscopy (APC)	Day 0 (Procedure Day)
Secondary	Assessment screening	Adenomas Per Positive Patient (APP)	Day 0 (Procedure Day)
Secondary	Assessment screening	Sessile Serrated Adenoma Detection Rate	Day 0 (Procedure Day)
Secondary	Assessment Screening	Polyp Detection Rate (PDR)	Day 0 (Procedure Day)
Secondary	Procedural Outcomes	Procedure Time: Time to cecum and withdrawal time	Day 0 (Procedure Day)
Secondary	Procedural Outcomes	Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented.	Day 0 (Procedure Day)

External Links

•   More information about Pure-VU® EVS