To evaluate the performance of MCS in cleansing a poorly prepared colon.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the performance of MCS in cleansing a poorly prepared colon.
The rate of adequate cleansing level per subject will be evaluated by the BBPS
(The Boston Bowen preparation Scale) scoring index pre- and post the cleansing
operation.
Secondary outcome
To evaluate the safety related to the MCS. To this purpose, the type,
incidence, severity, and duration of adverse events will be assessed.
Background summary
Colonoscopy is an endoscopic examination of the colonic mucosa. The procedure
is considered the *gold standard* for detecting, diagnosing and treating
abnormalities in the colon and is widely used for various clinical indications.
High-quality colonoscopy is imperative for enhancing efficacy of and for
decreasing the costs associated with the procedure. A key factor for ensuring
high quality colon visualization using colonoscopy is a good colon preparation.
Despite the importance of good preparation, many patients do not or are not
able to adequately prepare themselves prior to the
colonoscopy procedure. It is estimated that as many as 33% of colonoscopy
patients arrive for their colonoscopy with inadequate colon preparation1.
Factors that contribute to poor preparation include inconvenience and
discomfort of ingesting cleansing agents
(laxatives), concerns about lost work days, contraindication to cleansing
agents, obesity and immobility due to medical condition or old age. Achieving a
good level of colon preparation is one of the major barriers to successful and
cost effective colonoscopy for colorectal cancer screening as well as for
diagnosis of other gastrointestinal conditions.
Motus Cleansing System (MCS) facilitates a thoroughly-cleansed bowel for
subjects with a poorly prepared colon. By providing intra-procedural mechanical
colon cleansing, the MCS reduces reliance on subject pre-procedure colon
preparation for ensuring high quality colonoscopy. By offering simple, fast,
safe and effective intra-procedural cleansing, the MCS is expected to improve
the quality of colonoscopy to reduce the need for repeat colonoscopies, to
increase the patient compliance to colonoscopy procedure and to reduce the
patient dependency on the quality of the procedure.
Study objective
To evaluate the performance of MCS in cleansing a poorly prepared colon.
Study design
Prospective, multi-center, single-arm, open-label study
Intervention
Use of Motus Cleansing System (MCS)to enable 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.
Study burden and risks
The potential risks associated with the participation in the clinical
investigation may include a repeated colonoscopy procedure as the subjects
enrolled to the study are required to undergo a limited prep as compared to the
preparation given prior to standard colonoscopy procedure to mimic a poor colon
preparation.
Based on previous clinical data an excellent cleansing effectiveness was
demonstrated following the use of the MCS device ; MCS improved the cleansing
level from 30% at baseline to 93% after the cleansing was operated, where the
preparation in these studies were identical to the preparation in current
study, for further detailed please refer to the "clinical evaluation report"
(see pages 5-8 of the Risk Benefit assessment document).
Therefore, it is expected that the risk of a repeated colonoscopy procedure is
low.
Keren Hayesod 22
Tirat Carmel 3902638
IL
Keren Hayesod 22
Tirat Carmel 3902638
IL
Listed location countries
Age
Inclusion criteria
1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent
Exclusion criteria
1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA>=IV
6. Renal insufficiency (Creatinine >= 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST >= 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs or dual antiplatelet therapy
9. Subjects with known coagulation disorder (INR >1.5).
10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
11.Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
12.Subjects with known Mega Colon
13 Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54357.091.15 |