Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.
following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motus CleanC System | Experimental | Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 |
|
| Motus Cleansing System Rev 2.5 | Experimental | Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 |
|
| Motus Cleansing System Rev 3.0 | Experimental | Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motus Cleansing System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System. | Following the colonoscopic procedure- Up to 24 hours. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ravit Peled | Motus GI Technologies Ltd. | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients had to follow a specific bowel preparation in order to mimic poor bowel preparation:
Arm 1: start clear liquid diet 24 hours prior to the procedure Arm 2: start clear liquid diet 24 hours prior to the procedure Arm 3: start clear liquid diet 18 hours prior to the procedure along with 4 tables of 5 mg Bisacodyl in split dose
The study was conducted in 3 phases:
Phase 1 - enrolled 6 subjects using Rev 2.0 of the device Phase 2 - enrolled 21 subjects using Rev 2.5 of the device Phase 3 - enrolled 20 subjects using Rev 3.0 of the device
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Motus CleanC Syetem Rev 2.0 | 6 subjects used the second version of the device |
| FG001 | Motus Cleansing System Rev 2.5 | 21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5 |
| FG002 | Motus Cleansing System Rev 3.0 | 20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Motus CleanC System Rev 2.0 | Motus CleanC System Rev 2.0 |
| BG001 | Motus Cleansing System Rev 2.5 | Motus Cleansing System Rev 2.5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System. | subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) | Posted | Count of Participants | Participants | Following the colonoscopic procedure- Up to 24 hours. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motus CleanC Syetem Rev 2.0 | 6 subjects used the second version of the device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel perforation | Gastrointestinal disorders | Systematic Assessment | The head design comprises flexible balcony-like in the tip which was beyond the scope's field of view, are suspected as the cause for the perforation. The event was resolved with a scar as a residual effect. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Gastrointestinal disorders | Systematic Assessment | mild laceration resolved with no clinical sequelae within two days |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravit Peled -Director of Clinical Trial | Motus GI Medical Technologies Ltd. | +972 526145354 | ravit@motusgi.com |
Not provided
Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Not provided
Not provided
Not provided
Not provided
| BG002 | Motus Cleansing System Rev 3.0 | Motus Cleansing System Rev 3.0 |
| BG003 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Motus Cleansing System Rev 2.5 |
Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 Motus Cleansing System |
| OG002 | Motus Cleansing System Rev 3.0 | Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 Motus Cleansing System |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 3 |
| 6 |
| EG001 | Motus Cleansing System Rev 2.5 | 21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5 | 0 | 21 | 0 | 21 | 2 | 21 |
| EG002 | Motus Cleansing System Rev 3.0 | 20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0 | 0 | 20 | 0 | 20 | 0 | 20 |
|
|
| Erosion | Gastrointestinal disorders | Systematic Assessment | mild erosion resolved with no clinical sequelae |
|
| Submucosal Hematoma | Gastrointestinal disorders | Systematic Assessment | mild Hematoma resolved with no clinical sequelae |
|
Not provided
Not provided