- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922906
Recruitment Status Recruiting
First Posted April 22, 2019
Last update posted February 26, 2020
The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.
The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure. Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime. Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
|Experimental: Motus Pure-Vu System
The Pure-Vu System 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: Pure-Vu System
Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Subjects with history of inadequate bowel preparation.
2. Subjects in the age range of 22-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent
1. Patients with active Inflammatory Bowel Disease
2. Patients with previous history of acute diverticulitis disease or with prior
incomplete colonoscopy due to diverticular disease
3. Patients with known bowel obstruction / strictures
4. History of prior surgery to colon and/or rectum
5. ASA ≥ III
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
8. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
9. Patients with known coagulation disorder (INR >1.5).
10. Patients at risk of hypokalemia or hyponatremia
11. Patients with congestive cardiac failure
12. Pregnancy (as stated by patient) or breast feeding
13. Patients with altered mental status/inability to provide informed consent
14. Patients who have participated in another interventional clinical study in the last 2
Contact: Ravit Peled 0526145354 email@example.com
Chaim Sheba Medical Center
Motus GI Medical Technologies Ltd