NCT05585879

Demonstrating Effective Salvage of Inadequate Colonoscopies

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Colorectal Screening

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2022-10-19
• Last updated: 2024-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study