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NCT03026075: MCS

Evaluation of the Performance of the Motus Cleansing System (MCS)

Completed NA Results posted Last updated 11 February 2019
What this trial tests

NA trial testing Motus Cleansing System (MCS) in CRC in 47 participants. Completed in 31 May 2017.

Timeline
22 December 2016
Primary endpoint
31 May 2017
31 May 2017

Quick facts

Lead sponsorMotus GI Medical Technologies Ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment47
Start date22 December 2016
Primary completion31 May 2017
Estimated completion31 May 2017
Sites3 locations across Netherlands, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Motus GI Medical Technologies Ltd

Who can join

Adults 18 to 75, any sex, with CRC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Performance of MCS in Cleansing a Poorly Prepared Colon. Primary · 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.

adequate cleaning after the use of MCS
GroupValue95% CI
Colonoscopy With MCS46
adequate cleaning at baseline
GroupValue95% CI
Colonoscopy With MCS9

Adverse events — posted to ClinicalTrials.gov

Time frame: Follow up was conducted immediately after the procedure before patient discharge and at 2-3 days and 14-16 days post procedure. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Colonoscopy With MCS
Serious: 0/47 (0%)
Deaths: 0/47
Other adverse events (1 terms — click to expand)

ReactionSystemColonoscopy With MCS
BloatingGastrointestinal disorders

Data from ClinicalTrials.gov NCT03026075 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for CRC

Currently open trials in the same condition.

Other Motus GI Medical Technologies Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03026075.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing