CRCMCSNCT03026075
Evaluation of the Performance of the Motus Cleansing System (MCS)
A study testing Motus Cleansing System (MCS) in people with CRC, run by Motus GI Medical Technologies Ltd at 3 sites in 2 countries.
Trial summary
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC
- What is being tested?
- Motus Cleansing System (MCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Dec 2016to 31 May 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 being considered for diagnostic, screening or surveillance colonoscopy
- Subjects in the age range of 18-75 years inclusive
- Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
- Subject has signed the informed consent
Who cannot join
- Subjects with known Inflammatory Bowel Disease
- Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- Subjects with known or detected (during colonoscopy) bowel obstruction
- History of prior surgery to colon and/or rectum
- ASA≥IV
- Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
Show all 15Show fewer
- Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
- Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
- Subjects with known coagulation disorder (INR >1.5).
- Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
- Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
- Subjects with known Mega Colon
- Pregnancy (as stated by patient) or breast feeding
- Subjects with altered mental status/inability to provide informed consent
- Patients who have participated in another interventional clinical study in the last 2 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology
Nijmegen
Erasmus medical center
Rotterdam
About this study
Official title: Evaluation of the Performance of the Motus Cleansing System
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.
Read the detailed description
Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).
Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).
- Conditions
- CRC
- Being tested
- Motus Cleansing System (MCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motus Cleansing System (MCS)Device
The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with MCS | Experimental | Standard colonoscopy procedure with Motus Cleansing System Receives: Device: Motus Cleansing System (MCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of MCS in Cleansing a Poorly Prepared Colon.
The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
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 posted20 Jan 2017 (estimated)
- Study start22 Dec 2016
- Primary completion31 May 2017
- Study completion31 May 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT03026075
- Sponsor's protocol ID
- CL00016
- Acronym
- MCS
- Status last verified
- Jun 2017
- First submitted
- 17 Jan 2017
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.
PubMed 29996152
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. 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
- NCT03026075
- Acronym / sponsor ID
- MCS / CL00016
- Conditions
- CRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.
Detailed description
Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).
Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with MCS | Experimental | Device: Motus Cleansing System (MCS)Standard colonoscopy procedure with Motus Cleansing System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects being considered for diagnostic, screening or surveillance colonoscopy
- Subjects in the age range of 18-75 years inclusive
- Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
- Subject has signed the informed consent
Key exclusion criteria (15 listed)
- Subjects with known Inflammatory Bowel Disease
- Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- Subjects with known or detected (during colonoscopy) bowel obstruction
- History of prior surgery to colon and/or rectum
- ASA≥IV
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 System (MCS)The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. | Device | Colonoscopy with MCS |
Primary outcome
Performance of MCS in Cleansing a Poorly Prepared Colon.
Time frame: Up to 2 hours
The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29996152van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.
- Individual participant dataSharing planned: Undecided
Related trials for CRC
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motus Cleansing System (MCS) in people with CRC, run by Motus GI Medical Technologies Ltd at 3 sites in 2 countries.
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 15 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Germany. 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 11 Feb 2019). 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?
Performance of MCS in Cleansing a Poorly Prepared Colon. (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?
On the ClinicalTrials.gov record for NCT03026075, which also lists 1 linked publication.
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 11 Feb 2019.