Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
Completed · Not applicable
Conditions studied: Gastrointestinal Disease, Colorectal Cancer
In brief
The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
Key facts
- Study ID
- NCT03503162
- Run by
- Motus GI Medical Technologies Ltd
- People needed
- 95
- Starts
- 2018-05-17
- Expected to finish
- 2019-05-20
- Last updated by the study team
- 2021-04-13
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
- Patients' age > 22 years
- Patient has signed the informed consent
You may not qualify if…
- Patients with known Inflammatory Bowel Disease and / or active Colitis
- Patients with active diverticulitis
- Patients with known or detected (during colonoscopy) bowel obstruction
- Patients with BMI ≤ 18
- Patients with ascites Child Pugh C
- Patients who are 30 days post-transplant
- Patients treated with Peritoneal dialysis
- Patients under active IV inotropic medications
- Patients with LVAD
- Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician)
- Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
- Subjects with hemodynamic instability.
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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