Clinical and Urgent Colonoscopy Outcomes Using the Pure-Vu® Cleansing System

NCT04729946 | Terminated FDA Device

• 1 other identifier: 20-884
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The Pure-Vu® System can be effectively used as a cleansing device in patients admitted with acute LGIB to the intensive care unit and the regular nurse floor (RNF) bypassing the need to administer an oral bowel preparation for adequate visualization and hence decreasing time to colonoscopy and improving diagnostic and therapeutic yield.

Conditions

Lower Gastrointestinal Bleeding; Hemostatic Disorder

Keywords

Colonoscopy; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Adequate Bowel Preparation

  The proportion of participants who achieve an adequate bowel preparation to identify bleeding lesions

  During the colonoscopy procedure, typically less than 1 hour

Secondary Outcomes (3)

• Diagnostic yield

  During the colonoscopy procedure, typically less than 1 hour

• Therapeutic Yield

  During the colonoscopy procedure, typically less than 1 hour

• Re-bleeding rate

  48 hours post-colonoscopy

Study Arms (1)

Pure-Vu Treatment

EXPERIMENTAL

Participants in this arm will undergo colonoscopy using the Pure-Vu cleansing device.

Device: Pure-Vu Cleansing Device

Interventions

Pure-Vu Cleansing Device DEVICE

The Pure-Vu device attaches to the colonoscope and provides colonic cleansing during urgent colonoscopy without the need for a bowel preparation

Pure-Vu Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients in the ICU or the RNF with acute LGIB (defined as maroon-colored stool or bright red blood per rectum with suspicion of acute blood loss anemia, and hemodynamically stable and/or stabilized at the time of procedure . Hospitalized patients include:
• Patients who develop LGIB while admitted for different reasons
• Patients transferred from an outside hospital for further management of acute LGIB
• Patients admitted through the emergency room for management of acute LGIB
• At least 22 years old
• Undergoing urgent colonoscopy under monitored anesthesia care or conscious sedation

You may not qualify if:

• Suspicion for bowel obstruction/ stricture
• Toxic megacolon or severe colitis (determined by degree of colitis on imaging and clinical condition including pain, fevers, abdominal exam, elevated inflammatory markers)
• Active Diverticulitis

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Motus GI Medical Technologies Ltd: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brian Baggott, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking is planned
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Operations

Model Details: Single-Center Pilot Study

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: March 3, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)