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N/A N=10 Screening

Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

CRC

Bottom Line

View on ClinicalTrials.gov: NCT02572076 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS — 9 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Motus Cleansing System (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Motus GI Medical Technologies Ltd
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS		 9 —

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.

Eligibility Criteria

Inclusion Criteria

  • Subjects being considered for diagnostic, screening or surveillance colonoscopy
  • Subjects in the age range of 18-75 years inclusive
  • Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
  • Subject has signed the informed consent

Exclusion Criteria

  • 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)
  • Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
  • Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02572076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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