Trial Outcomes & Findings for Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT NCT03503162)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

up to 2 hours

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Colonoscopy With Pure-Vu System Inpatient colonoscopies with Pure-Vu System- Single Arm Pure-Vu System: The Pure-Vu System is FDA cleared device 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.
Overall Study STARTED	95
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Colonoscopy With Pure-Vu System Inpatient colonoscopies with Pure-Vu System- Single Arm Pure-Vu System: The Pure-Vu System is FDA cleared device 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.
Overall Study did not meet eligibility	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colonoscopy With Pure-Vu System n=94 Participants Inpatient colonoscopies with Pure-Vu System- Single Arm Pure-Vu System: The Pure-Vu System is FDA cleared device 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.
Age, Customized	62.44 years n=94 Participants
Sex: Female, Male Female	38 Participants n=94 Participants
Sex: Female, Male Male	56 Participants n=94 Participants
Region of Enrollment United States	69 participants n=94 Participants
Region of Enrollment Germany	25 participants n=94 Participants

PRIMARY outcome

Timeframe: up to 2 hours

Population: Rate of Adequacy of bowel preparation using the Boston Bowel Preparation Score (BBPS)

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.

Outcome measures

Outcome measures
Measure	Colonoscopy With Pure-Vu System n=84 Participants Inpatient colonoscopy procedure with Pure-Vu System Pure-Vu System: 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.
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System Rate of adequate preparation measured by BBPS before Pure-Vu Use	38 Percentage of Adequate cleansing Interval 28.0 to 49.0
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System Rate of adequate preparation measured by BBPS after Pure-Vu Use	96 Percentage of Adequate cleansing Interval 90.0 to 99.0

Adverse Events

Colonoscopy With Pure-Vu System

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Colonoscopy With Pure-Vu System n=94 participants at risk Inpatient colonoscopy procedure with Pure-Vu System Pure-Vu System: 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.
Gastrointestinal disorders Perforation	1.1% 1/94 • Number of events 1 • From procedure to 48 hours post procedure

Other adverse events

Other adverse events
Measure	Colonoscopy With Pure-Vu System n=94 participants at risk Inpatient colonoscopy procedure with Pure-Vu System Pure-Vu System: 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.
Gastrointestinal disorders Fever	1.1% 1/94 • Number of events 1 • From procedure to 48 hours post procedure
Gastrointestinal disorders abdominal pain	1.1% 1/94 • Number of events 1 • From procedure to 48 hours post procedure
Gastrointestinal disorders Drop in Hemoglobin	1.1% 1/94 • Number of events 1 • From procedure to 48 hours post procedure

Additional Information

Director of Clinical Operations

Motus GI

Phone: 954-541-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place