Clinical trial NCT04700410: Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation
Official title: A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colonic Adenoma
Bowel Preparation
Keywords: Bowel preparation
colonoscopy
colorectal cancer
adenoma detection rate
endoscopy
therapeutic irrigation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: University Medical Center Mainz
name: Motus GI Medical Technologies Ltd
First posted: 2021-01-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm international multicenter colonoscopy trial
Primary purpose: SCREENING

Brief summary: The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.

Detailed description: Rationale: It is widely acknowledged that the efficacy and safety of colonoscopy depends on the quality of the pre-procedural bowel preparation. Despite its importance, the proportion of colonoscopies with inadequate bowel preparation still ranges from 6.8-33% across studies. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. (1, 2) Evidence to recommend a specific bowel cleansing regimen in these patients is currently lacking. (3) Mostly, patients with previous bowel preparation are advised to drink more oral purgatives, which is very difficult and unpleasant for patients and therefore often fails.

The aim of this study is to evaluate if an intra-procedural bowel cleaning device, the Pure-VuTM System (Tirat Carmel, Israel) can be used to achieve an adequate level of bowel cleansing in patients with previous poor bowel preparation.

Objective: The aim of this study is to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale \[BBPS\]\<6).

Study design: We will perform a single arm international multicenter colonoscopy trial. Adult patients with previous poor bowel preparation (BBPS\<6) will be invited to participate in our study (n= 44). All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS will be assessed before and after segmental washing by the endoscopist who performs the procedure and later by an independent endoscopist (photos).

Study population: Adult patients with poor bowel preparation within the last 2 years. Exclusion criteria; previous colon resection, previous colorectal cancer, colitis, lower gastrointestinal bleeding with hemodynamic instability, ASA\>3, insufficiently corrected anticoagulation disorders, inability to provide informed consent.

Primary endpoint: The primary endpoint of the study will be the BBPS-score before and after intra-procedural bowel cleaning with the Pure-Vu System.

Secondary endpoints include:

* Total number of colon lesions specified by histology
* Adenoma detection rate
* Cecal intubation rates
* Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
* Total amount of water used for washing and total amount of fluids+residual stool removed.
* Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
* System usability
* Endoscopists' learning curve
* Safety outcomes

Nature and extent of the burden and risk associated with participation, benefit and group relatedness: Colonoscopy is a commonly performed procedure and the overall serious adverse event (SAE) rate is low, around 2.8 per 1000 colonoscopies. The risk of adverse events (AE) with the Pure-Vu are believed to be equivalent to conventional colonoscopy, including bleeding and perforation risks (13). Participation in this study could potentially benefit colonoscopy patients because the Pure-Vu is expected to improve the quality of colonoscopy. Inadequate bowel cleansing may be prevented by the Pure-Vu System. Inadequate bowel cleansing is associated with lower adenoma detection rates (ADR), lower completion rates, longer procedure times, more complications and a higher need for repeat procedures.(4, 5) In addition, Pure-Vu reduces the reliance on patients pre-procedural bowel preparation which is often considered the most deterrent part of colonoscopy by patients.

Eligibility criteria: Inclusion Criteria:

* Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
* Poor bowel preparation within the last 2 years, defined as a BBPS \<6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation

Exclusion Criteria:

* Prior colon resection
* Previous colorectal cancer
* Colitis
* Lower gastrointestinal bleeding with hemodynamic instability
* Bowel obstruction
* Pregnancy or lactating
* ASA \> 3
* Insufficiently corrected anticoagulation disorders
* Inability to provide informed consent

Primary outcomes:
measure: Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
timeFrame: 1 day (day of intervention)
measure: Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system.
timeFrame: 1 day (day of intervention)
Secondary outcomes:
measure: Total number of colon lesions specified by histology
timeFrame: 1 day (day of intervention)
measure: Adenoma detection rate
timeFrame: 1 day (day of intervention)
measure: Cecal intubation rates
timeFrame: 1 day (day of intervention)
measure: Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
timeFrame: 1 day (day of intervention)
measure: Total amount of water used for washing and total amount of fluids+residual stool removed.
timeFrame: 1 day (day of intervention)
measure: Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
timeFrame: 1 month
measure: System usability
timeFrame: through study completion, an average of 1 year
measure: Endoscopists' learning curve
timeFrame: through study completion, an average of 1 year
measure: Number of adverse events after study intervention
timeFrame: 48 hours and 1month after intervention
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: