Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation
Condition: Colorectal Cancer; Colonic Adenoma; Bowel Preparation
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional

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.
    

Intervention name(s): Pure-Vu System
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: single arm international multicenter colonoscopy trial
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Bowel preparation; colonoscopy; colorectal cancer; adenoma detection rate; endoscopy; therapeutic irrigation