Gastrointestinal DiseasesNCT03493009
Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
A study testing Pure-Vu System in people with Gastrointestinal Diseases and Colorectal Cancer, run by Motus GI Medical Technologies Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Colorectal Cancer
- What is being tested?
- Pure-Vu System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects scheduled for colonoscopy procedure
- Subjects in the age range of 22-75 years inclusive
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Who cannot join
- Patients with active Inflammatory Bowel Disease
- Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- Patients with known bowel obstruction
- Patient with chronic constipation
- History of prior surgery to colon and/or rectum
- ASA (Physical status classification system) ≥ III
Show all 12Show fewer
- Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
- Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
- Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
- Patients with known coagulation disorder (INR >1.5).
- Pregnancy (as stated by patient) or breast feeding
- Patients with altered mental status/inability to provide informed consent
About this study
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Diseases, Colorectal Cancer
- Being tested
- Pure-Vu System
- Medical subject headings
- Gastrointestinal Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure-Vu SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 10mg Magnesium citrate | Experimental | 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 Receives: Device: Pure-Vu System |
| 15mg Magnesium citrate | Experimental | 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 Receives: Device: Pure-Vu System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 May 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: Difficulties to sign a contract with the hospital, due to logistic changes in the hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in blocks will be applied for each site to allocate patients to one of two different bowel preparation regimens (Prep A- split doae of 10mg of Magnesium citrate versus Prep B- split doae of 15mg of Magnesium citrate). The study will utilize randomization in blocks using the standard envelope procedure, which will be applied in order to allocate patients into two arms: * 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus GI Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493009
- Sponsor's protocol ID
- CL00042
- Status last verified
- Dec 2017
- First submitted
- 27 Dec 2017
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan to share the individual participated date with other researchers at this point.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
- ClinicalTrials.gov ID
- NCT03493009
- Acronym / sponsor ID
- CL00042
- Conditions
- Gastrointestinal Diseases, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties to sign a contract with the hospital, due to logistic changes in the hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in blocks will be applied for each site to allocate patients to one of two different bowel preparation regimens (Prep A- split doae of 10mg of Magnesium citrate versus Prep B- split doae of 15mg of Magnesium citrate). The study will utilize randomization in blocks using the standard envelope procedure, which will be applied in order to allocate patients into two arms: * 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.
| Arm | Type | Receives |
|---|---|---|
| 10mg Magnesium citrate | Experimental | Device: Pure-Vu Systemsubjects 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 |
| 15mg Magnesium citrate | Experimental | Device: Pure-Vu Systemsubjects 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 |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects scheduled for colonoscopy procedure
- Subjects in the age range of 22-75 years inclusive
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Key exclusion criteria (12 listed)
- Patients with active Inflammatory Bowel Disease
- Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- Patients with known bowel obstruction
- Patient with chronic constipation
- History of prior surgery to colon and/or rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure-Vu SystemThe 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. | Device | 10mg Magnesium citrate, 15mg Magnesium citrate |
Primary outcome
rate of adequate cleansing level
Time frame: up to 2 hours
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Individual participant dataSharing planned: Undecided. no plan to share the individual participated date with other researchers at this point.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pure-Vu System in people with Gastrointestinal Diseases and Colorectal Cancer, run by Motus GI Medical Technologies Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of adequate cleansing level (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.