Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
NCT ID: NCT03493009
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-05-01
2018-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group 1 - Will go through the Prep A procedure
* Group 2 - Will go through the Prep B procedure The site randomization plan will be provided to the study coordinator prior the study start.
SCREENING
NONE
Study Groups
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10mg Magnesium citrate
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
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.
15mg Magnesium citrate
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects in the age range of 22-75 years inclusive
3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Exclusion Criteria
2. Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Patients with known bowel obstruction
4. Patient with chronic constipation
5. History of prior surgery to colon and/or rectum
6. ASA (Physical status classification system) ≥ III
7. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
8. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
9. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
10. Patients with known coagulation disorder (INR \>1.5).
11. Pregnancy (as stated by patient) or breast feeding
12. Patients with altered mental status/inability to provide informed consent
22 Years
75 Years
ALL
Yes
Sponsors
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Motus GI Medical Technologies Ltd
INDUSTRY
Responsible Party
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CL00042
Identifier Type: -
Identifier Source: org_study_id