Clinical trial · Interventional
Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation
A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Preparation | — | UNRESOLVED | — |
| Colonic Adenoma | Colon Adenoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pure-Vu System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pure-Vu
- description
- 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 (single arm)
- interventionNames
- Device: Pure-Vu System
Primary outcomes (2)
- measure
- Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
- timeFrame
- 1 day (day of intervention)
- description
- Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0\) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available