N/A
N=95
Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
Gastrointestinal Disease · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03503162 ↗Enrolled (actual)
95
Serious AEs
1.1%
Results posted
Apr 2021
Primary outcome: Primary: The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System — 38; 96 Percentage of Adequate cleansing
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pure-Vu System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Motus GI Medical Technologies Ltd
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System |
38; 96 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
- Patients' age > 22 years
- Patient has signed the informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03503162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.