COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700410
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
University Medical Center Mainz
Motus GI Medical Technologies Ltd
Information provided by (Responsible Party):
Radboud University

Brief Summary:
The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colonic Adenoma Bowel Preparation Device: Pure-Vu System Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single arm international multicenter colonoscopy trial
Masking: None (Open Label)
Masking Description: Independent assessment of BBPS (photos).
Primary Purpose: Screening
Official Title: A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
Estimated Study Start Date : February 14, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: Pure-Vu
All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System (single arm)
Device: Pure-Vu System
All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System.




Primary Outcome Measures :
  1. Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system. [ Time Frame: 1 day (day of intervention) ]

    Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows:

    0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared.

    1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
    2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well.
    3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.

  2. Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system. [ Time Frame: 1 day (day of intervention) ]

    Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows:

    0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared.

    1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
    2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well.
    3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.


Secondary Outcome Measures :
  1. Total number of colon lesions specified by histology [ Time Frame: 1 day (day of intervention) ]
  2. Adenoma detection rate [ Time Frame: 1 day (day of intervention) ]
  3. Cecal intubation rates [ Time Frame: 1 day (day of intervention) ]
  4. Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions) [ Time Frame: 1 day (day of intervention) ]
  5. Total amount of water used for washing and total amount of fluids+residual stool removed. [ Time Frame: 1 day (day of intervention) ]
  6. Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale) [ Time Frame: 1 month ]
    A visual analogue scale from 0 to 10, in which higher numbers indicate a higher level of discomfort.

  7. System usability [ Time Frame: through study completion, an average of 1 year ]

    general ease of use, ease of rectum insertion, ease of angulation, ease of advancement, device stiffness, ease of polyp resection holding forces, ease of retroflexion,

    • Unacceptable
    • Difficult
    • Acceptable
    • Good (as good as conventional colonoscopy)
    • Excellent

  8. Endoscopists' learning curve [ Time Frame: through study completion, an average of 1 year ]
  9. Number of adverse events after study intervention [ Time Frame: 48 hours and 1month after intervention ]
    Safety outcomes (adverse events): Severe adverse events will be subcategorized cardiac (cardiac ischemia, heart failure, arrhythmia, other) pulmonary (exacerbation of Chronic Obstructive Pulmonary Disease, infectious, other), neurological (stroke, cerebrovascular accident, bleeding, other), and other (surgical interventions etc.).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
  • Poor bowel preparation within the last 2 years, defined as a BBPS <6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation

Exclusion Criteria:

  • Prior colon resection
  • Previous colorectal cancer
  • Colitis
  • Lower gastrointestinal bleeding with hemodynamic instability
  • Bowel obstruction
  • Pregnancy or lactating
  • ASA > 3
  • Insufficiently corrected anticoagulation disorders
  • Inability to provide informed consent

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): NCT04700410


Locations
Layout table for location information
Germany
University Medical Center Mainz
Mainz, Germany
Contact: Helmut Neumann, professor    6131 17 6836 ext +49    tanja.bender@unimedizin-mainz.de   
Netherlands
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525GA
Sponsors and Collaborators
Radboud University
University Medical Center Mainz
Motus GI Medical Technologies Ltd
Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04700410    
Other Study ID Numbers: NL66613.091.18
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University:
Bowel preparation
colonoscopy
colorectal cancer
adenoma detection rate
endoscopy
therapeutic irrigation
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type