Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Motus Cleansing System
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS [Within 24 hours- During the colonoscopy procedure]
The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS>1 in all colon segments
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HaEemek Medical Center | 'Afula | IL | Israel |
Sponsors and Collaborators
- Motus GI Medical Technologies Ltd
Investigators
- Principal Investigator: Ian Gralnek, PHD, HaEmek Medical Center, Afula Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CL00035
Study Results
Participant Flow
| Recruitment Details | all patients recruited between Feb 2016 to Dec 2016 at "Emek Medical Center", Afula Israel. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Motus Cleansing System (MCS) |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 9 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Motus Cleansing System (MCS) |
|---|---|
| Arm/Group Description | 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. Motus Cleansing System |
| Overall Participants | 9 |
| Age (YEARS) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [YEARS] |
46.5
(13.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
55.6%
|
| Male |
4
44.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
9
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS |
|---|---|
| Description | The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS>1 in all colon segments |
| Time Frame | Within 24 hours- During the colonoscopy procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Motus Cleansing System (MCS) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 9 |
| Count of Participants [Participants] |
9
100%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Motus Cleansing System (MCS) |
|---|---|---|
| Comments | patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon. | |
| Type of Statistical Test | Other | |
| Comments | Pilot study- no sample size was calculated | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | number of subjects with adequate cleansi |
| Estimated Value | 100 | |
| Confidence Interval |
(2-Sided) 95% 66 to 100 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Motus Cleansing System (MCS) | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Motus Cleansing System (MCS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Serious Adverse Events |
||
| Motus Cleansing System (MCS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Motus Cleansing System (MCS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Ravit Peled -Director of Clinical Trial |
|---|---|
| Organization | Motus GI Medical Technologies Ltd. |
| Phone | 0733243823 ext 203 |
| ravit@motusgi.com |
- CL00035