Status:
COMPLETED
Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
University Medical Center Mainz
Motus GI Medical Technologies Ltd
Conditions:
Colorectal Cancer
Colonic Adenoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04700410
Start Date
June 1 2021
End Date
May 1 2022
Last Update
November 21 2024
Active Locations (2)
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1
University Medical Center Mainz
Mainz, Germany
2
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525GA