Colonoscopy ProcedureMSCNCT02161536
Evaluation of the Performance of the Motus Cleansing System
A study testing Motus Cleansing System in people with Colonoscopy Procedure, run by Motus GI Medical Technologies Ltd.
Trial summary
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Procedure
- What is being tested?
- Motus Cleansing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects in the age range of 18-75 years
- Subjects with BMI within the range of 18.5-35
- Subject is willing to sign informed consent form
Who cannot join
- Active or severe IBD
- Subjects with severe diverticulitis \ diverticular disease (known or detected)
- Known or detected colonic stenosis
- Known or detected bowel obstruction
- History of prior colon surgery
- ASA≥IV (sever systemic disease)
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- Sever Renal insufficiency
- Sever Liver insufficiency
- Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent pregnancy
- Subjects with altered mental status/inability to provide informed consent
- Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
About this study
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
Read the detailed description
Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.
following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.
- Conditions
- Colonoscopy Procedure
- Being tested
- Motus Cleansing System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motus Cleansing SystemDevice
Also called Motus CleanC
| Study group | Role | What they receive |
|---|---|---|
| Motus CleanC System | Experimental | Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 Receives: Device: Motus Cleansing System |
| Motus Cleansing System Rev 2.5 | Experimental | Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 Receives: Device: Motus Cleansing System |
| Motus Cleansing System Rev 3.0 | Experimental | Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 Receives: Device: Motus Cleansing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem
The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) .
Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.
Measured: Following the colonoscopic procedure- Up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonoscopy ProcedureStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus GI Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravit Peled, Study director, Motus GI Technologies Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161536
- Sponsor's protocol ID
- CP-MCC-SA-0214
- Acronym
- MSC
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2014
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the Motus Cleansing System
- ClinicalTrials.gov ID
- NCT02161536
- Acronym / sponsor ID
- MSC / CP-MCC-SA-0214
- Conditions
- Colonoscopy Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 6 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
Detailed description
Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.
following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
| Arm | Type | Receives |
|---|---|---|
| Motus CleanC System | Experimental | Device: Motus Cleansing SystemColonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 |
| Motus Cleansing System Rev 2.5 | Experimental | Device: Motus Cleansing SystemColonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 |
| Motus Cleansing System Rev 3.0 | Experimental | Device: Motus Cleansing SystemColonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects in the age range of 18-75 years
- Subjects with BMI within the range of 18.5-35
- Subject is willing to sign informed consent form
Key exclusion criteria (11 listed)
- Active or severe IBD
- Subjects with severe diverticulitis \ diverticular disease (known or detected)
- Known or detected colonic stenosis
- Known or detected bowel obstruction
- History of prior colon surgery
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 |
|---|---|---|
| Motus Cleansing SystemAlso: Motus CleanC | Device | Motus CleanC System, Motus Cleansing System Rev 2.5, Motus Cleansing System Rev 3.0 |
Primary outcome
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem
Time frame: Following the colonoscopic procedure- Up to 24 hours.
The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ravit Peled study director
Motus GI Technologies Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing Motus Cleansing System in people with Colonoscopy Procedure, 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 11 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: finished, as of the sponsor's last update on 6 Nov 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?
Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem (time frame: Following the colonoscopic procedure- Up to 24 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 6 Nov 2018.