A new method for bowel cleansing in patients with a history of poor bowel preparation * A multicenter feasibility study with the Pure-Vu

A new method for bowel cleansing in patients with a history of poor bowel preparation * A multicenter feasibility study with the Pure-Vu - Pure-Vu II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49503

Enrollment

Registered

2019-03-18

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal neoplasms

Interventions

Pure-Vu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18 years or older, referred for colonoscopy, previous inadequate bowel preparation

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study will be the BBPS-score before and after intra-procedural bowel cleaning with the Pure-Vu.	—

Secondary

Measure	Time frame
* 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 washing, 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 * Operator learning curve * Safety outcomes	—

Measure

Time frame

* 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 washing, 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 * Operator learning curve * Safety outcomes

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)