NCT03922906

Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Detailed description

The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure. Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime. Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.

Conditions

• CRC

Interventions

Type	Name	Description
DEVICE	Pure-Vu System	Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.

Timeline

• Start date: 2020-01-21
• Primary completion: 2020-02-25
• Completion: 2021-02-02
• First posted: 2019-04-22
• Last updated: 2021-02-25

Locations

1 site across 1 country: Israel