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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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

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CRC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Colonoscopy with MCS

Standard colonoscopy procedure with Motus Cleansing System

Group Type EXPERIMENTAL

Motus Cleansing System (MCS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA≥IV
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
9. Subjects with known coagulation disorder (INR \>1.5).
10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
11. Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
12. Subjects with known Mega Colon
13. Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes