NCT03503162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

April 9, 2018

Results QC Date

September 14, 2020

Last Update Submit

March 18, 2021

Conditions

Gastrointestinal DiseaseColorectal Cancer

Keywords

bowel prepartion

Outcome Measures

Primary Outcomes (1)

  • The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System

    The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated using the Boston Bowel Preparation Scale (BBPS). Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.

    up to 2 hours

Study Arms (1)

Colonoscopy with Pure-Vu System

EXPERIMENTAL

Standard colonoscopy procedure with Pure-Vu System

Device: Pure-Vu System

Interventions

Pure-Vu SystemDEVICE

The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.

Colonoscopy with Pure-Vu System

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 34022813DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesColorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Director of Clinical Operations
Organization
Motus GI
anniec@motusgi.com
954-541-8000

Study Officials

  • Annie Choi

    Motus GI Technologies Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 19, 2018

Study Start

May 17, 2018

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

April 13, 2021

Results First Posted

April 13, 2021

Record last verified: 2020-10

Locations

US(1)