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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285008
Recruitment Status : Withdrawn (Sponsor has terminated study due to COVID-19 related concerns)
First Posted : February 26, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Motus GI Medical Technologies Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Colorectal Cancer Device: Pure-Vu System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to Intervention or Control arm will use stratification by site, endoscopist and blocking. Sites are expected to contribute approximately equal numbers of procedures, and no site will be allowed to contribute more than 50% of the target sample size. The randomization sequences will be provided in advance by the study's statistician using an online system to obtain the randomization assignment and the corresponding colonoscope will be prepared. Randomization assignment will be recorded for each subject.
Masking: Single (Participant)
Masking Description: The Colonoscope will be prepared as per normal routine and the research assistant will cover the colonoscope before the patient enters the endoscopy room to keep him/her blinded to the study arm. This is uncovered once the patient is sedated.
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: standard Colonoscopy

Control arm

Colonoscopy procedure using standard flushing and suctioning - standard of care

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.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285008


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Motus GI Medical Technologies Ltd
  Study Documents (Full-Text)

Documents provided by Motus GI Medical Technologies Ltd:
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Responsible Party: Motus GI Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT04285008    
Other Study ID Numbers: CL00048
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Motus GI Medical Technologies Ltd:
colonoscopy
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases