Colorectal PolypDiscoveryIIINCT05220345
Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.
A study testing colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) in people with Colorectal Polyp and Colonoscopy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Colonoscopy, Artificial Intelligence
- What is being tested?
- colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2022to 26 Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years)
- Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.
Who cannot join
- Inflammatory bowel disease (IBD)
- Known polyp or tumor upon referral
- Therapeutic procedure (e.g., endoscopic mucosal resection)
- Prior surgical resection of any portion of the colon
- American Society of Anesthesiologists score of ≥3
- Inadequately corrected anticoagulation disorder or anticoagulation medication use
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center Nijmegen
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With Artificial Intelligence Assisted Polyp Detection (Discovery System) on Adenoma Detection Rate. 'Discovery III Study'
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.
Read the detailed description
Rationale: Colonoscopy is the gold standard for CRC screening. The adenoma detection rate (ADR) is the most important quality parameter for colonoscopy, because of its inverse association with the risk of interval CRC. Yet, the adenoma miss rate (AMR) in conventional colonoscopy is reported in meta-analyses to vary between 22-26%. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colonic mucosa during the procedure. To increase the adenoma detection rate (ADR), new polyp/adenoma detection systems based on artificial intelligence (AI) have been developed, i.e., computer assisted detection (CADe). However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions. Therefore, we hypothesize that ADR can further be improved by combining a CADe system, the Discovery system, with a behind the fold (BTF) visualization technique, the G-Eye.
Study design: International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135). All subjects will be undergoing colonoscopy with a combined BFT and CADe assisted approach. Outcomes will be corrected for confounders using regression modeling.
Study population: 194 Adult patients (>18 years) from 3 hospitals, scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion criteria: inflammatory bowel disease (IBD), known polyp or tumor upon referral, therapeutic procedure (e.g. endoscopic mucosal resection), prior surgical resection of any portion of the colon, American Society of Anesthesiologists score of ≥3, Inadequately corrected anticoagulation disorders or anticoagulation medication use, inability to provide informed consent.
Main study endpoints: The primary objective of the present study is to compare ADR between CADe assisted and a combined BTF/CADe assisted colonoscopy. Secondary objectives include advanced neoplasia rate (including advanced adenomas and/or CRC), polyp detection rate, size and histopathology, mean number of polyps per patient, procedure times, bowel cleaning levels, adverse events, inter-operator variability.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Eligible patients who are scheduled for surveillance colonoscopy will undergo one BFT and CADe assisted colonoscopy. There will be no burden for participants regarding the colonoscopy procedure. Colonoscopy is a commonly performed procedure, and the overall serious adverse event rate is low with an estimated risk 2.8 per 1000 colonoscopies. The risk of experiencing a (serious) adverse event with G-Eye and Discovery guided colonoscopy is believed to be equivalent to conventional colonoscopy. The benefit for patients is a higher likelihood of lesion detection during colonoscopy.
- Conditions
- Colorectal Polyp, Colonoscopy, Artificial Intelligence, Adenoma
- Being tested
- colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)Device
All participants will be subjected to a colonoscopy procedure, assisted by both G-eye balloon and the Discovery CADe system. Standard of care regarding the colonoscopy procedure will be applied to all study subjects. Any lesions detected during the procedure will be removed directly
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy with a combined BFT and CADe assisted approach | Other | This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy. Receives: Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Calculated as the number of patients in whom at least one adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure.
Measured: 30 days after procedure
Secondary outcomes (19)
Advanced adenoma detection rate (AADR).
calculated as the number of patients in whom at least one advanced adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure
Measured: 30 days after procedure
Polyp Detection Rate
calculated as the number of patients in whom at least one polyp is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure
Measured: 30 days after procedure
Sessile detection Rate
calculated as the number of patients in whom at least one SSL is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure
Measured: 30 days after procedure
Indication specific ADR,
ADR specific for screening, diagnostic, or surveillance
Measured: 30 days after procedure
Mean number of adenomas detected per patient
Mean number of adenomas detected per patient
Measured: 30 days after procedure
Mean number of polyps detected per patient
Mean number of polyps detected per patient
Measured: 30 days after procedure
Number of sessile serrated lesions
Number of sessile serrated lesions
Measured: 30 days after procedure
Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD
Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD
Measured: 30 days after procedure
Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm
Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm
Measured: During procedure
Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum;
Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum;
Measured: During procedure
Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)
Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)
Measured: During procedure
Histopathological characteristics of the lesion according to the Vienna classification
Histopathological characteristics of the lesion according to the Vienna classification
Measured: 30 days after procedure
ADR of the first 20% of patients that have undergone colonoscopy by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial
ADR of the first 20% of patients that have undergone colonoscopy by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial
Measured: At end of study
Bowel cleansing
Using the Boston Bowel Prep Scale
Measured: During procedure
Cecal intubation rate (CIR)
Cecal intubation rate (CIR)
Measured: During procedure
Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)
Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)
Measured: During procedure
Severe) adverse events (S)AEs up to 30 days post-procedure
SAEs will be subcategorized into colonoscopy related, cardiac (cardiac ischemia, heart failure, arrhythmia, other) pulmonary (exacerbation COPD, infectious, other), neurological (stroke, cerebrovascular accident, bleeding, other), and other (surgical interventions etc.)
Measured: 30 days after procedure
Gloucester Comfort Scale score and analgesia use
Gloucester Comfort Scale score and analgesia use
Measured: During procedure
Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines
Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines
Measured: 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start12 May 2022
- Primary completion26 Aug 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135).
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- PENTAX Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Peter D Siersema, Prof, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220345
- Sponsor's protocol ID
- NL80004.091.21
- Acronym
- DiscoveryIII
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset used during this study is available from the corresponding author upon reasonable request.
Publications
Maas MHJ, van Riswijk MLM, Rath T, Cesaro P, Salvi D, Siersema PD; DISCOVERY III study group. Effect of Combination of a Mucosal Exposure Device and Computer-Aided Detection in Diagnostic, Screening, and Surveillance Colonoscopy: An International, Multicenter Study. Clin Transl Gastroenterol. 2026 Feb 1;17(2):e00963. doi: 10.14309/ctg.0000000000000963.
PubMed 41363762
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With Artificial Intelligence Assisted Polyp Detection (Discovery System) on Adenoma Detection Rate. 'Discovery III Study'
- ClinicalTrials.gov ID
- NCT05220345
- Acronym / sponsor ID
- DiscoveryIII / NL80004.091.21
- Conditions
- Colorectal Polyp, Colonoscopy, Artificial Intelligence, Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- PENTAX Europe GmbH
- Study start
- 12 May 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 2 Feb 2022 (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.
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.
Detailed description
Rationale: Colonoscopy is the gold standard for CRC screening. The adenoma detection rate (ADR) is the most important quality parameter for colonoscopy, because of its inverse association with the risk of interval CRC. Yet, the adenoma miss rate (AMR) in conventional colonoscopy is reported in meta-analyses to vary between 22-26%. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colonic mucosa during the procedure. To increase the adenoma detection rate (ADR), new polyp/adenoma detection systems based on artificial intelligence (AI) have been developed, i.e., computer assisted detection (CADe). However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions. Therefore, we hypothesize that ADR can further be improved by combining a CADe system, the Discovery system, with a behind the fold (BTF) visualization technique, the G-Eye.
Study design: International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135). All subjects will be undergoing colonoscopy with a combined BFT and CADe assisted approach. Outcomes will be corrected for confounders using regression modeling.
Study population: 194 Adult patients (>18 years) from 3 hospitals, scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion criteria: inflammatory bowel disease (IBD), known polyp or tumor upon referral, therapeutic procedure (e.g. endoscopic mucosal resection), prior surgical resection of any portion of the colon, American Society of Anesthesiologists score of ≥3, Inadequately corrected anticoagulation disorders or anticoagulation medication use, inability to provide informed consent.
Main study endpoints: The primary objective of the present study is to compare ADR between CADe assisted and a combined BTF/CADe assisted colonoscopy. Secondary objectives include advanced neoplasia rate (including advanced adenomas and/or CRC), polyp detection rate, size and histopathology, mean number of polyps per patient, procedure times, bowel cleaning levels, adverse events, inter-operator variability.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Eligible patients who are scheduled for surveillance colonoscopy will undergo one BFT and CADe assisted colonoscopy. There will be no burden for participants regarding the colonoscopy procedure. Colonoscopy is a commonly performed procedure, and the overall serious adverse event rate is low with an estimated risk 2.8 per 1000 colonoscopies. The risk of experiencing a (serious) adverse event with G-Eye and Discovery guided colonoscopy is believed to be equivalent to conventional colonoscopy. The benefit for patients is a higher likelihood of lesion detection during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135).
| Arm | Type | Receives |
|---|---|---|
| colonoscopy with a combined BFT and CADe assisted approach | Other | Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years)
- Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.
Key exclusion criteria (7 listed)
- Inflammatory bowel disease (IBD)
- Known polyp or tumor upon referral
- Therapeutic procedure (e.g., endoscopic mucosal resection)
- Prior surgical resection of any portion of the colon
- American Society of Anesthesiologists score of ≥3
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 |
|---|---|---|
| colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)All participants will be subjected to a colonoscopy procedure, assisted by both G-eye balloon and the Discovery CADe system. Standard of care regarding the colonoscopy procedure will be applied to all study subjects. Any lesions detected during the procedure will be removed directly | Device | colonoscopy with a combined BFT and CADe assisted approach |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: 30 days after procedure
Calculated as the number of patients in whom at least one adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure.
19 secondary outcomes
Advanced adenoma detection rate (AADR).
Time frame: 30 days after procedure
Polyp Detection Rate
Time frame: 30 days after procedure
Sessile detection Rate
Time frame: 30 days after procedure
Indication specific ADR,
Time frame: 30 days after procedure
Mean number of adenomas detected per patient
Time frame: 30 days after procedure
Mean number of polyps detected per patient
Time frame: 30 days after procedure
Number of sessile serrated lesions
Time frame: 30 days after procedure
Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD
Time frame: 30 days after procedure
Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm
Time frame: During procedure
Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum;
Time frame: During procedure
Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)
Time frame: During procedure
Histopathological characteristics of the lesion according to the Vienna classification
Time frame: 30 days after procedure
ADR of the first 20% of patients that have undergone colonoscopy by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial
Time frame: At end of study
Bowel cleansing
Time frame: During procedure
Cecal intubation rate (CIR)
Time frame: During procedure
Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)
Time frame: During procedure
Severe) adverse events (S)AEs up to 30 days post-procedure
Time frame: 30 days after procedure
Gloucester Comfort Scale score and analgesia use
Time frame: During procedure
Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines
Time frame: 30 days after procedure
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 15 Aug 2025.
- Derived from this study: PubMed 41363762Maas MHJ, van Riswijk MLM, Rath T, Cesaro P, Salvi D, Siersema PD; DISCOVERY III study group. Effect of Combination of a Mucosal Exposure Device and Computer-Aided Detection in Diagnostic, Screening, and Surveillance Colonoscopy: An International, Multicenter Study. Clin Transl Gastroenterol. 2026 Feb 1;17(2):e00963. doi: 10.14309/ctg.0000000000000963.
- Individual participant dataSharing planned: Yes. The dataset used during this study is available from the corresponding author upon reasonable request.
Related trials for Colorectal Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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.
Peter D Siersema, Prof principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) in people with Colorectal Polyp and Colonoscopy, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 7 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 15 Aug 2025. 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 Netherlands. 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?
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 (ADR) (time frame: 30 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220345, which also lists 1 linked publication.
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 15 Aug 2025.