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Pure-Vu EVS for Colorectal Screening

N/A
Recruiting
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 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

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 more
Other 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.

Find a Location

Who is running the clinical trial?

Motus GI Medical Technologies LtdLead Sponsor
12 Previous Clinical Trials
348 Total Patients Enrolled
Aasma Shaukat, MDPrincipal InvestigatorNYU Langone.org

Media Library

Pure-Vu EVS Clinical Trial Eligibility Overview. Trial Name: NCT05585879 — N/A
Colorectal Screening Research Study Groups: Pure-Vu EVS
Colorectal Screening Clinical Trial 2023: Pure-Vu EVS Highlights & Side Effects. Trial Name: NCT05585879 — N/A
Pure-Vu EVS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585879 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort enrolled in this research endeavor?

"Affirmative. The clinicaltrials.gov webpage reflects that the trial, first posted on November 3rd 2022 is still actively recruiting individuals to participate. It is expected that 1067 patients from two different sites are needed for this experiment."

Answered by AI

Are participants aged 20 and above qualified to join this trial?

"This clinical trial welcomes individuals who are 40 years and older but not yet 80."

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Has recruitment for this trial commenced yet?

"This trial is still seeking applicants, as reported on clinicaltrials.gov. The initial posting was made November 3rd 2022 and the latest update occurred November 15th of the same year."

Answered by AI

Is there any way I can participate in this research project?

"To gain admittance to the trial, applicants must have undergone mutagenicity tests and fall into the age range of 40-80. At present there are approximately 1067 participants."

Answered by AI
~442 spots leftby Apr 2025