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Evaluation of the Performance of the CleanC System-Israel

NCT ID: NCT02387268

Last Updated: 2017-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).

Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Conditions

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Colorectal Cancer (CRC) Screening

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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CleanC

Standard colonoscopy procedure using the CleanC system

Group Type EXPERIMENTAL

CleanC system

Intervention Type DEVICE

Cleansing liquid and fecal matter during a standard colonoscopy procedure

Interventions

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CleanC system

Cleansing liquid and fecal matter during a standard colonoscopy procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects in the age range of 18-75 years
2. Subjects with BMI within the range of 18.5-35
3. Subject is willing to sign informed consent form

Exclusion Criteria

1. Active or severe inflammatory bowel disease (IBD)
2. Subjects with severe diverticulitis \\ diverticular disease (known or detected)
3. Known or detected colonic stenosis
4. Known or detected bowel obstruction
5. History of prior colon surgery
6. ASA≥IV (sever systemic disease)
7. Sever Renal insufficiency (Creatinine≥1.5mg%)
8. Sever Liver insufficiency (ALT/AST≥2UNL)
9. Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent
10. pregnancy
11. Subjects with altered mental status/inability to provide informed consent
12. Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Motus GI Medical Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CL00005

Identifier Type: -

Identifier Source: org_study_id