Demonstrating Effective Salvage of Inadequate Colonoscopies

NCT05585879 | Terminated DMC FDA Device

• 1 other identifier: CL00052
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Assessment of Screening

  Day 0 (Procedure Day)

• Assessment of Screening

  Day 0 (Procedure Day)

• Procedural Outcome

  Day 0 (Procedure Day)

• Procedural Outcome

  Day 0 (Procedure Day)

• Assessment screening

  Day 0 (Procedure Day)

Other Outcomes (3)

• User Satisfaction

  Day 0(Procedure Day)

• Comparison Rates

  Day 0 (Procedure Day) - 1-14 day follow up

• Economic Impact

  Through study completion, an average of 1 year.

Study Arms (1)

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: * 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.

Device: Pure-Vu EVS

Interventions

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: * Boston Bowel Preparation Score (BBPS) \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify \> 5mm polyps

Pure-Vu EVS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible adults aged between 40-80
• Elective outpatient colonoscopy by participating gastroenterologist

You may not qualify if:

• Not competent to consent
• Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
• History of colonic resection
• Prior incomplete colonoscopy due to patient anatomy
• Diverticulitis
• Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
• Known or suspected colon stricture
• Hereditary Colorectal Cancer Syndrome
• Subject is pregnant or suspected pregnant

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

Study Sites (1)

NYU

New York, New York, 02241, United States

Location

Related Links

• More information about Pure-VU® EVS

Study Officials

• Mark Pomeranz

  Motus GI Medical Technologies Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 19, 2022
• Study Start: November 3, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon completion of the study.
• Access Criteria: clinicaltrials.gov

Locations

US (1)