Evaluation of the Performance of the CleanC System-Israel

NCT02387268 | Completed Results DMC

• 1 other identifier: CL00005
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer (CRC) Screening

Outcome Measures

Primary Outcomes (2)

• Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )

  Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.

  During the colonoscopy procedure withdrawal phase (10 min in average)

• Safety as Measured by Number of Serious Adverse Events and Major Complications.

  Max of 9 days

Secondary Outcomes (1)

• Percentage of Participants in Whom the Cecum Was Reached

  During the colonoscopy procedure

Study Arms (1)

CleanC

EXPERIMENTAL

Standard colonoscopy procedure using the CleanC system

Device: CleanC system

Interventions

CleanC system DEVICE

Cleansing liquid and fecal matter during a standard colonoscopy procedure

CleanC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active or severe inflammatory bowel disease (IBD)
• Subjects with severe diverticulitis \\ diverticular disease (known or detected)
• Known or detected colonic stenosis
• Known or detected bowel obstruction
• History of prior colon surgery
• ASA≥IV (sever systemic disease)
• Sever Renal insufficiency (Creatinine≥1.5mg%)
• Sever Liver insufficiency (ALT/AST≥2UNL)
• Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent
• pregnancy
• Subjects with altered mental status/inability to provide informed consent
• 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

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr.Kobie Dickstein
• Organization: M.C.Carmel

kobiedi@clalit.org.il

048250055

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 12, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 20, 2017
• Results First Posted: March 7, 2016

Record last verified: 2016-02