Colonic PolypNCT04837599
Artificial Intelligence Performance in Colonoscopy in Daily Practice
A study testing Discovery TM of Pentax medical on/off in colonoscopy in people with Colonic Polyp and Adenoma, run by Gastroenterologie Baden-Wettingen at 1 site in Switzerland.
Trial summary
randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Colonic Polyp, Adenoma
- What is being tested?
- Discovery TM of Pentax medical on/off in colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2021to 31 Oct 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients referred and fit for an ambulant colonoscopy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Martin Geyer
Wettingen, Canton of Aargau, 5430
Martin Geyer, MD, 0562227292, geyer@gastro-bw.ch
About this study
Official title: Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without
randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).
The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).
Read the detailed description
From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.
- endpoint is time gain in the different phase of the colonoscopy
- endpoint is adenoma detection rate (ADR)
- Conditions
- Colonic Polyp, Adenoma
- Being tested
- Discovery TM of Pentax medical on/off in colonoscopy
- Keywords
- artificial intelligence
- Medical subject headings
- Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discovery TM of Pentax medical on/off in colonoscopyDevice
Also called Endocuff mounted yes/no
on the monitor artificial integlligence Discovery can be switched on or off.
| Study group | Role | What they receive |
|---|---|---|
| Pentax i 10 | No intervention | Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence |
| Pentax i 10 with artificial intelligence Discovery TM | Active comparator | Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence Receives: Device: Discovery TM of Pentax medical on/off in colonoscopy |
| Pentax i 10 with Endocuff TM | Active comparator | Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate. Receives: Device: Discovery TM of Pentax medical on/off in colonoscopy |
| Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM | Active comparator | Endocuff cap is mounted on the tip of the endoscope and artificial intelligence is activated on the monitor. hypothesis is that probably artificial intelligence and Endocuff combined potentiate their effect. Receives: Device: Discovery TM of Pentax medical on/off in colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy time
measurement of ascent, descent and intervention time during colonoscopy
Measured: within 45 minutes of examination
Secondary outcomes (1)
polyp and adenoma detetction rate PDR and ADR
counts of polypes and their location in the colon and their histology
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 posted8 Apr 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gastroenterologie Baden-Wettingen
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Geyer Martin, Gastroenterologie Baden-Wettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837599
- Sponsor's protocol ID
- Gastro BW 1
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without
- ClinicalTrials.gov ID
- NCT04837599
- Acronym / sponsor ID
- Gastro BW 1
- Conditions
- Colonic Polyp, Adenoma
- Keywords
- artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Gastroenterologie Baden-WettingenUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).
The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).
Detailed description
From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.
- endpoint is time gain in the different phase of the colonoscopy
- endpoint is adenoma detection rate (ADR)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pentax i 10 | No intervention | –Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence |
| Pentax i 10 with artificial intelligence Discovery TM | Active comparator | Device: Discovery TM of Pentax medical on/off in colonoscopyNormal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence |
| Pentax i 10 with Endocuff TM | Active comparator | Device: Discovery TM of Pentax medical on/off in colonoscopyEndocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate. |
| Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM | Active comparator | Device: Discovery TM of Pentax medical on/off in colonoscopyEndocuff cap is mounted on the tip of the endoscope and artificial intelligence is activated on the monitor. hypothesis is that probably artificial intelligence and Endocuff combined potentiate their effect. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients referred and fit for an ambulant colonoscopy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Discovery TM of Pentax medical on/off in colonoscopyAlso: Endocuff mounted yes/noon the monitor artificial integlligence Discovery can be switched on or off. | Device | Pentax i 10 with Endocuff TM, Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM, Pentax i 10 with artificial intelligence Discovery TM |
Primary outcome
Endoscopy time
Time frame: within 45 minutes of examination
measurement of ascent, descent and intervention time during colonoscopy
1 secondary outcome
polyp and adenoma detetction rate PDR and ADR
Time frame: within 45 minutes of examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discovery TM of Pentax medical on/off in colonoscopy in people with Colonic Polyp and Adenoma, run by Gastroenterologie Baden-Wettingen at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopy time (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 19 Apr 2021.