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

Motus GI

Status: Completed

Conditions: Gastrointestinal Disease; Colorectal Cancer

Treatments: Device: Pure-Vu System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03503162

CL00044

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
2. Patients' age > 22 years
3. Patient has signed the informed consent

Exclusion criteria

1. Patients with known Inflammatory Bowel Disease and / or active Colitis
2. Patients with active diverticulitis
3. Patients with known or detected (during colonoscopy) bowel obstruction
4. Patients with BMI ≤ 18
5. Patients with ascites Child Pugh C
6. Patients who are 30 days post-transplant
7. Patients treated with Peritoneal dialysis
8. Patients under active IV inotropic medications
9. Patients with LVAD
10. 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)
11. Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
12. Subjects with hemodynamic instability.
13. Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Colonoscopy with Pure-Vu System

Experimental group

Description:

Standard colonoscopy procedure with Pure-Vu System

Treatment:

Device: Pure-Vu System