Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
1 other identifier
interventional
175
1 country
1
Brief Summary
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2022
CompletedJuly 23, 2021
July 1, 2021
2.2 years
May 21, 2020
July 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Lesions detected
Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
Baseline
Secondary Outcomes (7)
Detection rate of dysplastic lesions
Baseline
Non-dysplastic lesions
Baseline
Ratio of neoplastic lesions/total lesions
Baseline
Total endoscopy time
Baseline
Removal time
Baseline
- +2 more secondary outcomes
Study Arms (2)
Chromoendoscopy with methylene blue 0.1%
ACTIVE COMPARATOROnce the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied.
Virtual Chromoendoscopy with NBI with HQ190 endoscopes
EXPERIMENTALIntubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode
Interventions
Chromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions.
Eligibility Criteria
You may qualify if:
- Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy
You may not qualify if:
- Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
- Known allergy or intolerance to methylene blue
- Pregnant or lactating women
- Personal history of colorectal cancer
- Ulcerative colitis active more than 20 cm from the anal verge
- Patients with known G6PD deficiency
- Severe kidney failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, 28046, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Martín Arranz, PhD
Hospital Universitario La Paz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 27, 2020
Study Start
October 1, 2019
Primary Completion
December 30, 2021
Study Completion
February 25, 2022
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share