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Demonstrating Effective Salvage of Inadequate Colonoscopies

NCT05585879 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Colorectal Screening

Interventions

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

Sponsors & Collaborators

  • Motus GI Medical Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Mark Pomeranz · Motus GI Medical Technologies Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2024-04-26
Completion
2024-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585879 on ClinicalTrials.gov