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Pure-Vu EVS for Colorectal Screening
N/A
Waitlist Available
Led By Aasma Shaukat, MD
Research Sponsored by Motus GI Medical Technologies Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
Study Summary
This trial tests a device to help make sure colonoscopies are done properly, so they can be effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Colonoscopy
Secondary outcome measures
Assessment Screening
Assessment of Screening
Assessment screening
+2 moreOther outcome measures
Comparison Rates
Economic Impact
User Satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pure-Vu EVSExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Motus GI Medical Technologies LtdLead Sponsor
12 Previous Clinical Trials
348 Total Patients Enrolled
Mark PomeranzStudy DirectorMotus GI Medical Technologies Ltd
Aasma Shaukat, MDPrincipal InvestigatorNYU Langone.org
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a genetic condition that increases your risk of developing colorectal cancer.You have a narrowed colon or suspected blockage in your colon.You have diverticulitis, an inflammation in your digestive tract.You have had surgery to remove part of your colon in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Pure-Vu EVS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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