Evaluation of the Performance of the CleanC System-Israel

Motus GI

Status: Completed

Conditions: Colorectal Cancer (CRC) Screening

Treatments: Device: CleanC system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387268

CL00005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CleanC

Experimental group

Description:

Standard colonoscopy procedure using the CleanC system

Treatment:

Device: CleanC system