An interventional study of Pure-Vu System in Gastrointestinal Diseases and Colorectal Cancer, sponsored by Motus GI Medical Technologies Ltd. Withdrawn. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Motus GI Medical Technologies Ltd · Not applicable, Interventional, and Screening
The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.
This multicenter, prospective, randomized study will include up to 100 patients (30 patients per site and 15 patients per study arm), aimed at evaluating the performance of Pure-Vu System in cleansing patients' colon who are indicated for colonoscopy procedure using one of two different preparation regimes as detailed below.
Subjects will be enrolled at up to 10 clinical sites in the United States. Subjects who meet the eligibility criteria will be randomly allocated to a given study arm and will be required to follow a specific bowel preparation instruction along with a specific prep agent (Bowel preparation instructions for morning and afternoon procedures are provided in appendix B1 and B2, respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix D).
In addition patient will be ask to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
Exclusion Criteria:
subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 10 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
Device: Pure-Vu System
subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 15 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
Device: Pure-Vu System
The Pure-Vu System is Food and Drug Administration (FDA) approved device since September 22, 2016, 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
The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated per study arm using the Boston Bowel Preparation Scale (BBPS). Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side). BBPS\* scores will be rated by the colonoscopies, on the basis of three segment scores summed for maximum score of 9, where: * 0 = unprepared * 9 = completely clean (in completed to Cecum procedures) An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.
Time frame: up to 2 hours
No study locations are listed for this record.
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Plan to share: Undecided — no plan to share the individual participated date with other researchers at this point.
This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Motus GI Medical Technologies Ltd