Clinical trial NCT03503162: Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
Official title: Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Colorectal Cancer
Keywords: bowel prepartion
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2018-04-19
Enrollment: 95
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
timeFrame: up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Motus GI Technologies Ltd.
name: Annie Choi
role: STUDY_DIRECTOR
References:
citation: Neumann H, Latorre M, Zimmerman T, Lang G, Samarasena J, Gross S, Brahmbhatt B, Pazwash H, Kushnir V. A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study. BMC Gastroenterol. 2021 May 22;21(1):232. doi: 10.1186/s12876-021-01817-2.