Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice
Primary Purpose
Adenoma Detection Rate
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
difference between colonoscopes
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma Detection Rate
Eligibility Criteria
Inclusion Criteria:
- all patient fit for ambulatory colonoscopy
Exclusion Criteria:
- for Endocuff stricturing divertculosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
FUSE
HD Pentax i10 colonoscopes
Endocuff
Arm Description
wide angle colonoscope
SFV instrument
Cuff on SFV
Outcomes
Primary Outcome Measures
Adenoma detection rate
adenoma counts
Secondary Outcome Measures
time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS
different endoscopy characteristics
Full Information
NCT ID
NCT04472741
First Posted
July 11, 2020
Last Updated
February 8, 2021
Sponsor
Gastroenterologie Baden-Wettingen
1. Study Identification
Unique Protocol Identification Number
NCT04472741
Brief Title
Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice
Official Title
Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) High Definition Colonoscopes in Daily Practice
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gastroenterologie Baden-Wettingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its intended purpose)
Detailed Description
From March 2015 through February 2017 (phase A) patients referred for ambulant colonoscopy in a private Swiss gastroenterologist's practice were alternatingly allocated to one of the two endoscopy theatres. One equipped with a FUSE® endoscopy system from Endochoice (later: Boston Scientific, nA/FUSE®=1044 examinations), the other with an EPKi Processor and Pentax i10 colonoscopes (nA/Pentax=934 examinations). In March 2017 a second doctor joined the practice, but did not contribute to the study. These organizational changes required randomization to be switched from per-patient alternation to per-day alternation in phase B from March 2018 through September 2019. In phase B the FUSE® system was unchanged (nB/FUSE®=1386 examinations), while the Pentax i10 colonoscopes were additionally equipped with Endocuff® (nB/Endocuff®=750 examinations). Patients with contraindica-tion against Endocuff® (known or found diverticular stenosis) were excluded from the study (nB/removed=127). Patients were given their appointments to any free slot throughout the week without stratification. The study and data analysis was consented by the ethical committee EKNZ Ethikkom-mission Nordwest- und Zentralschweiz (Project-ID 2019-01643).
All procedures were performed by one experienced endoscopist (board certified 2004) under nurse assisted propofol sedation (NAPS).
Baseline characteristics, age, sex, BMI, smoking habits, diabetes as well as quality of bowel prepara-tion (measured by BBPS score) and indication for colonoscopy (screening, surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were assessed. Amount of sedatives, other medications given during endoscopy (e.g. Buscopan®) and time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention time) and time for intervention were measured by the assistant with a stopwatch. These parameters, polyp counts, size and their localisation (entered in a table and to an anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall satisfaction) were realtime entered to the database by a tablet computer. The data entry was done coded. Only the main investigator could subdue each single patient.
Statistics were done with a professional statistics, the co-author Dr. Leiner
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Detection Rate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FUSE
Arm Type
Other
Arm Description
wide angle colonoscope
Arm Title
HD Pentax i10 colonoscopes
Arm Type
Other
Arm Description
SFV instrument
Arm Title
Endocuff
Arm Type
Other
Arm Description
Cuff on SFV
Intervention Type
Device
Intervention Name(s)
difference between colonoscopes
Intervention Description
patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
adenoma counts
Time Frame
within 45 minutes of examination
Secondary Outcome Measure Information:
Title
time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS
Description
different endoscopy characteristics
Time Frame
within 45 minutes of examination
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patient fit for ambulatory colonoscopy
Exclusion Criteria:
for Endocuff stricturing divertculosis
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice
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