Evaluation Of The Bowel Cleansing In Hospitalized Patients Using Pure-Vu System
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-003285
- Rochester, Minnesota: 18-003285
NCT ID: NCT03503162
Sponsor Protocol Number: Motus GI: CL00044
About this study
The aim of this study is to evaluate the potential improvement in colonoscopy procedure outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 consenPatients who have participated in another interventional clinical study in the last 2 months.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bhaumik Brahmbhatt, M.B.B.S., M.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator |
Closed for enrollment |
|
More information
Publications
Publications are currently not available