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
Last updated on July 2021Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 88
Summary
- Conditions
- Colorectal Cancer
- Gastrointestinal Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
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 b...
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.
Tracking Information
- NCT #
- NCT04285008
- Collaborators
- Not Provided
- Investigators
- Not Provided
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