Adenoma Detection RateNCT04472741
Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice
A study testing difference between colonoscopes in people with Adenoma Detection Rate, run by Gastroenterologie Baden-Wettingen.
Trial 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) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenoma Detection Rate
- What is being tested?
- difference between colonoscopes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,114 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patient fit for ambulatory colonoscopy
Who cannot join
- for Endocuff stricturing divertculosis
About this study
Official title: Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) High Definition Colonoscopes in Daily Practice
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)
Read the 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
- Conditions
- Adenoma Detection Rate
- Being tested
- difference between colonoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difference between colonoscopesDevice
patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
| Study group | Role | What they receive |
|---|---|---|
| FUSE | Other | wide angle colonoscope Receives: Device: difference between colonoscopes |
| HD Pentax i10 colonoscopes | Other | SFV instrument Receives: Device: difference between colonoscopes |
| Endocuff | Other | Cuff on SFV Receives: Device: difference between colonoscopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
adenoma counts
Measured: within 45 minutes of examination
Secondary outcomes (1)
time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS
different endoscopy characteristics
Measured: within 45 minutes of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Mar 2015
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Detection RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastroenterologie Baden-Wettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geyer Martin, Gastroenterologie Baden-Wettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472741
- Sponsor's protocol ID
- GastroBaWe
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) High Definition Colonoscopes in Daily Practice
- ClinicalTrials.gov ID
- NCT04472741
- Acronym / sponsor ID
- GastroBaWe
- Conditions
- Adenoma Detection Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,114 participants (actual)
- Lead sponsor
- Gastroenterologie Baden-WettingenUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FUSE | Other | Device: difference between colonoscopeswide angle colonoscope |
| HD Pentax i10 colonoscopes | Other | Device: difference between colonoscopesSFV instrument |
| Endocuff | Other | Device: difference between colonoscopesCuff on SFV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patient fit for ambulatory colonoscopy
Key exclusion criteria (1 listed)
- for Endocuff stricturing divertculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| difference between colonoscopespatients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff | Device | Endocuff, FUSE, HD Pentax i10 colonoscopes |
Primary outcome
Adenoma detection rate
Time frame: within 45 minutes of examination
adenoma counts
1 secondary outcome
time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS
Time frame: within 45 minutes of examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing difference between colonoscopes in people with Adenoma Detection Rate, run by Gastroenterologie Baden-Wettingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: within 45 minutes of examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.