CRCNCT02161549
Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
An observational study of CRC, run by Motus GI Medical Technologies Ltd at 1 site in Spain.
Trial summary
Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure. The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC
- What is being tested?
- Motus Gl CleanUp System
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Oct 2013
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)
Who may be able to join
- Subjects in the age range of 50-69 years
- Subjects who are considered for routine screening colonoscopy
- Subjects with BMI within the range of 18.5-30
- Subject is willing to sign informed consent form
Who cannot join
- History of G diseases or history of Colorectal cancer (personal or family)
- Previous major abdominal surgeries
- Medical status ASA grater or equal to 3
- Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
- Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
- Life-threatening condition
- Subjects who are unable or unwilling to cooperate with study procedures
- Severe Diverticula
Trial locations and contacts
1 site in 1 country.
About this study
Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.
The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.
Read the detailed description
63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.
40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:
- One head that irrigates and evacuates instead of two heads
- Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
- System adjustment to the above changes including updated software version.
- Conditions
- CRC
- Being tested
- Motus Gl CleanUp System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motus Gl CleanUp SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with MotusGi CleanUp System Rev 1.0 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Receives: Device: Motus Gl CleanUp System | |
| Colonoscopy with MotusGi CleanUp System Rev 1.5 | subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Receives: Device: Motus Gl CleanUp System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System
Measured: during colonoscopy procedure after cleansing with CleanUp System
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 2012
- Primary completionOct 2013
- Study completionOct 2013
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 CRCStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 2 Days
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
- NCT02161549
- Sponsor's protocol ID
- CP-MCU-SP-1211
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2014
- Last updated
- 20 Sep 2017
- 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 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT02161549
- Acronym / sponsor ID
- CP-MCU-SP-1211
- Conditions
- CRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 15 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.
The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.
Detailed description
63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.
40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:
- One head that irrigates and evacuates instead of two heads
- Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
- System adjustment to the above changes including updated software version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with MotusGi CleanUp System Rev 1.0 | – | Device: Motus Gl CleanUp Systemsubjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 |
| Colonoscopy with MotusGi CleanUp System Rev 1.5 | – | Device: Motus Gl CleanUp Systemsubjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)
Key inclusion criteria (4 listed)
- Subjects in the age range of 50-69 years
- Subjects who are considered for routine screening colonoscopy
- Subjects with BMI within the range of 18.5-30
- Subject is willing to sign informed consent form
Key exclusion criteria (8 listed)
- History of G diseases or history of Colorectal cancer (personal or family)
- Previous major abdominal surgeries
- Medical status ASA grater or equal to 3
- Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
- Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
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 Gl CleanUp System | Device | Colonoscopy with MotusGi CleanUp System Rev 1.0, Colonoscopy with MotusGi CleanUp System Rev 1.5 |
Primary outcome
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
Time frame: during colonoscopy procedure after cleansing with CleanUp System
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System
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: 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC, run by Motus GI Medical Technologies Ltd at 1 site in Spain.
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 4 inclusion and 8 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.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 15 Jun 2017). 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?
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System (time frame: during colonoscopy procedure after cleansing with CleanUp System). 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.