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)
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|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Recruitment Status : Withdrawn (Sponsor has terminated study due to COVID-19 related concerns)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
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Disease Colorectal Cancer||Device: Pure-Vu System||Not Applicable|
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:
- Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
- Colonoscopy procedural measures for Intervention and Control arms
- Endoscopists' experience
- Safety assessment for all subjects on the day of procedure per endoscopist
- Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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 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.|
|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|
No Intervention: standard Colonoscopy
Colonoscopy procedure using standard flushing and suctioning - standard of care
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.
- 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)
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
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|