Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System

This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure.

Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation.

Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system.

In case of inadequate bowel preparation, as per the nurse report and / or BBPS < 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu.

Follow-up will be conducted at 48 hours (± 48 hours) post procedure.

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