Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation (RESCue)

The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Gastrointestinal Disease
• Intervention / Treatment: Device: Pure-Vu System

Detailed Description

Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.

Subjects will be enrolled at up to 4 clinical sites in the United States.

primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)

The following secondary endpoints will be determined:

1. Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
2. Colonoscopy procedural measures for Intervention and Control arms
3. Endoscopists' experience
4. Safety assessment for all subjects on the day of procedure per endoscopist
5. Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
6. Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy

Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults > age 22
2. Elective outpatient colonoscopy by participating gastroenterologist
3. Stool clarity grade 1-3 at presentation for colonoscopy

Exclusion Criteria:

1. Not competent to consent
2. Bleeding disorder - known or suspected
3. Hereditary Gastrointestinal Cancer syndrome
4. Known PT INR > 1.5
5. Know elevated PTT
6. Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
7. Known platelet count < 50,000
8. Known absolute neutrophil count < 1,000
9. History of surgical colon resection
10. Pre-colonoscopy intent to enter terminal ileum
11. Prior incomplete colonoscopy due to technical & non-bowel preparation related reasons
12. Regular use of non-topical steroid
13. Pregnant
14. Prisoner or institutionalized for any reason
15. Psychiatric illness greater than mild
16. Colonoscopy without anesthesia administered (MAC) sedation
17. Diverticulitis
18. Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
19. Known or suspected colon stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard Colonoscopy; Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care
Other: Pure-Vu System; Intervention - Colonoscopy procedure using Pure-Vu System	Device: Pure-Vu System; The Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure	A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)	Up to 2 hours

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 15, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: CL00048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No