Colorectal Cancer (CRC) ScreeningNCT02387268
Evaluation of the Performance of the CleanC System-Israel
A study testing CleanC system in people with Colorectal Cancer (CRC) Screening, run by Motus GI Medical Technologies Ltd.
Trial summary
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC) Screening
- What is being tested?
- CleanC system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2015
- 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 inflammatory bowel disease (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)
Show all 12Show fewer
- Sever Renal insufficiency (Creatinine≥1.5mg%)
- Sever Liver insufficiency (ALT/AST≥2UNL)
- 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
Official title: Evaluation of the Performance of the "CleanC" System
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
Read the detailed description
The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).
Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
- Conditions
- Colorectal Cancer (CRC) Screening
- Being tested
- CleanC system
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanC systemDevice
Cleansing liquid and fecal matter during a standard colonoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| CleanC | Experimental | Standard colonoscopy procedure using the CleanC system Receives: Device: CleanC system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
Scale ranges- Min-0, Max-3 where:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
- = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
- = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
- = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.
Measured: During the colonoscopy procedure withdrawal phase (10 min in average)
Safety as Measured by Number of Serious Adverse Events and Major Complications.
Measured: Max of 9 days
Secondary outcomes (1)
Percentage of Participants in Whom the Cecum Was Reached
A procedure was considered complete when the cecum was reached and visualized.
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionNov 2015
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 Colorectal Cancer (CRC) ScreeningStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT02387268
- Sponsor's protocol ID
- CL00005
- Status last verified
- Feb 2016
- First submitted
- 2 Mar 2015
- Last updated
- 20 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant for primary and secondary outcome measures may be become available in the future
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the "CleanC" System
- ClinicalTrials.gov ID
- NCT02387268
- Acronym / sponsor ID
- CL00005
- Conditions
- Colorectal Cancer (CRC) Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
Detailed description
The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).
Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CleanC | Experimental | Device: CleanC systemStandard colonoscopy procedure using the CleanC system |
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 (12 listed)
- Active or severe inflammatory bowel disease (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 |
|---|---|---|
| CleanC systemCleansing liquid and fecal matter during a standard colonoscopy procedure | Device | CleanC |
Primary outcome
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
Time frame: During the colonoscopy procedure withdrawal phase (10 min in average)
Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.
Safety as Measured by Number of Serious Adverse Events and Major Complications.
Time frame: Max of 9 days
1 secondary outcome
Percentage of Participants in Whom the Cecum Was Reached
Time frame: During the colonoscopy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. De-identified individual participant for primary and secondary outcome measures may be become available in the future
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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 CleanC system in people with Colorectal Cancer (CRC) Screening, 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 7 Mar 2016). 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?
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) (time frame: During the colonoscopy procedure withdrawal phase (10 min in average)). The study lists 2 primary outcomes in all. 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 20 Sep 2017.