Colonoscopy Procedure
Conditions
Brief summary
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
Detailed description
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.
Interventions
DEVICEMotus Cleansing System
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Active or severe 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 * Sever Liver insufficiency * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | Following the colonoscopic procedure- Up to 24 hours. | 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. |
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Motus CleanC System Rev 2.0 Motus CleanC System Rev 2.0 | 6 |
| Motus Cleansing System Rev 2.5 Motus Cleansing System Rev 2.5 | 21 |
| Motus Cleansing System Rev 3.0 Motus Cleansing System Rev 3.0 | 20 |
| Total | 47 |
Baseline characteristics
| Characteristic | Motus CleanC System Rev 2.0 | Motus Cleansing System Rev 2.5 | Motus Cleansing System Rev 3.0 | Total |
|---|---|---|---|---|
| Age, Continuous | 48 YEARS STANDARD_DEVIATION 8.7 | 49.2 YEARS STANDARD_DEVIATION 11.6 | 54.7 YEARS STANDARD_DEVIATION 6.6 | 51.4 YEARS STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 14 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 3 / 6 | 2 / 21 | 0 / 20 |
| serious Total, serious adverse events | 1 / 6 | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: Following the colonoscopic procedure- Up to 24 hours.
Population: subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motus CleanC System | The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | 6 Participants |
| Motus Cleansing System Rev 2.5 | The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | 20 Participants |
| Motus Cleansing System Rev 3.0 | The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | 20 Participants |