Adenoma ColonNCT05158725
Comparison of Colonoscopy Adenoma Detection Yield
A study testing Standard Colonoscopy, Discovery aided colonoscopy and Discovery and G-EYE in people with Adenoma Colon, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
Trial summary
A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenoma Colon
- What is being tested?
- Standard Colonoscopy, Discovery aided colonoscopy and Discovery and G-EYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2021to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Screening and surveillance population for Adenoma and CRC.
- The patient must understand and sign a written informed consent for the procedure.
Who cannot join
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
- Subjects with a history of radiation therapy to abdomen or pelvis;
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- Pregnant or lactating female subjects;
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Wiesbaden, 65199
Ralf Kiesslich, Prof., +49 611 43-9002, Ralf.Kiesslich@helios-gesundheit.de
About this study
Official title: Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy
A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.
Read the detailed description
Multi-center, three-arm, randomized, controlled, open-label study.
Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):
Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery \& G-EYE® aided colonoscopy.
- Conditions
- Adenoma Colon
- Being tested
- Standard Colonoscopy, Discovery aided colonoscopy, Discovery and G-EYE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyDevice
In this arm, subjects will undergo colonoscopy using a standard colonoscope
Discovery aided colonoscopyDevice
the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
Discovery and G-EYEDevice
The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy | Active comparator | Subjects will undergo colonoscopy using a standard colonoscope Receives: Device: Standard Colonoscopy |
| Discovery aided colonoscopy | Active comparator | Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy Receives: Device: Discovery aided colonoscopy |
| Discovery and G-EYE aided colonoscopy | Experimental | Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy Receives: Device: Discovery and G-EYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection yield
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery \& G-EYE® aided colonoscopy
Measured: Upon histology results (up to 30 days)
Secondary outcomes (3)
Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)
Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Measured: Upon histology results (up to 30 days)
Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)
Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy
Measured: Upon histology results (up to 30 days)
Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)
Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy
Measured: Upon histology results (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start8 Nov 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma ColonStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multi-center, three-arm, randomized, controlled, open-label study
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Kiesslich, Prof., Principal investigator, Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158725
- Sponsor's protocol ID
- G-EYE/Discovery
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy
- ClinicalTrials.gov ID
- NCT05158725
- Acronym / sponsor ID
- G-EYE/Discovery
- Conditions
- Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Dec 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.
A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.
Detailed description
Multi-center, three-arm, randomized, controlled, open-label study.
Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):
Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery \& G-EYE® aided colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi-center, three-arm, randomized, controlled, open-label study
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy | Active comparator | Device: Standard ColonoscopySubjects will undergo colonoscopy using a standard colonoscope |
| Discovery aided colonoscopy | Active comparator | Device: Discovery aided colonoscopySubjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy |
| Discovery and G-EYE aided colonoscopy | Experimental | Device: Discovery and G-EYESubjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Screening and surveillance population for Adenoma and CRC.
- The patient must understand and sign a written informed consent for the procedure.
Key exclusion criteria (11 listed)
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
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 |
|---|---|---|
| Standard ColonoscopyIn this arm, subjects will undergo colonoscopy using a standard colonoscope | Device | Standard Colonoscopy |
| Discovery aided colonoscopythe Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery. | Device | Discovery aided colonoscopy |
| Discovery and G-EYEThe G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery | Device | Discovery and G-EYE aided colonoscopy |
Primary outcome
Adenoma detection yield
Time frame: Upon histology results (up to 30 days)
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery \& G-EYE® aided colonoscopy
3 secondary outcomes
Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)
Time frame: Upon histology results (up to 30 days)
Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)
Time frame: Upon histology results (up to 30 days)
Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)
Time frame: Upon histology results (up to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ralf Kiesslich, Prof. principal investigator
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Colonoscopy, Discovery aided colonoscopy and Discovery and G-EYE in people with Adenoma Colon, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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 11 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 15 Dec 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 Germany. 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?
Contact Ralf Kiesslich, Prof. (+49 611 43-9002, Ralf.Kiesslich@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection yield (time frame: Upon histology results (up to 30 days)). 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 15 Dec 2021.