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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 1, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
    • Time Frame: Up to 2 hours
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Motus GI Medical Technologies Ltd
  • Provider of Information About this Clinical Study
    • Sponsor

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