CRCNCT01838980

Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

A study testing Motus GI Clean-Up Device in people with CRC, run by Motus GI Medical Technologies Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Motus GI 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 GI Clean-Up Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: No sites listed yet
Study dates: Apr 2013to Feb 2014
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 50 to 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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 GI diseases or history of Colorectal cancer (personal or family)
Previous major abdominal surgeries
Medical status ASA grater or equal to 3
Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
Life-threatening condition
Subjects who are unable or unwilling to cooperate with study procedures
Severe Diverticula

About this study

Official title: Evaluation of the Motus GI CleanUp System During Screening

Conditions: CRC
Being tested: Motus GI Clean-Up Device
Keywords: Colonoscopy Cleaning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motus GI Clean-Up DeviceDevice

Study groups in NCT01838980
Study group	Role	What they receive
Colonoscopy	Experimental	Not described Receives: Device: Motus GI Clean-Up Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean of All Subjects Colon Segments BBPS>=2
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).
Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2.
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.

Apr 2013Feb 2014

First posted24 Apr 2013 (estimated)
Study startApr 2013
Primary completionFeb 2014
Study completionFeb 2014

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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01838980
Sponsor's protocol ID: CP-MCU-IL-0412
Status last verified: Apr 2014
First submitted: 21 Apr 2013
Last updated: 14 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided: De-identified individual participant data for all primary and secondary outcome measures may be made available in the future

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All CRC trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Motus GI CleanUp System During Screening
ClinicalTrials.gov ID: NCT01838980
Acronym / sponsor ID: CP-MCU-IL-0412
Conditions: CRC
Keywords: Colonoscopy Cleaning
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 13 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Colonoscopy	Experimental	Device: Motus GI Clean-Up Device

Who may qualify

Ages: 50 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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 GI diseases or history of Colorectal cancer (personal or family)
Previous major abdominal surgeries
Medical status ASA grater or equal to 3
Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
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 GI Clean-Up Device	Device	Colonoscopy

Primary outcome

Mean of All Subjects Colon Segments BBPS>=2
Time frame: Following the colonoscopic procedure- Up to 24 hours.
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2.

Results and safety

Results posted to the registry on 13 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colonoscopy	15	15

Primary outcome: Mean of All Subjects Colon Segments BBPS>=2

Time frame: Following the colonoscopic procedure- Up to 24 hours.. Mean (Standard Deviation). Unit: Mean of BBPS score per segment

Measure	Colonoscopy n = 14
Value	3 (0)

Population analysed: 15 subjects were enrolled to the study. 1 was excluded. Total of 14 subjects were analyzed.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colonoscopy	0 of 15 (0%)	6 of 15 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. De-identified individual participant data for all primary and secondary outcome measures may be made 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 Motus GI Clean-Up Device in people with CRC, 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 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 14 Feb 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 13 May 2014). 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 of All Subjects Colon Segments BBPS>=2 (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?

On the ClinicalTrials.gov record for NCT01838980.

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 14 Feb 2017.