Gastrointestinal NeoplasmsNEW-AGENCT04937647
Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy
An observational study of Gastrointestinal Neoplasms, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- collection of endoscopic images and videos
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2021to 27 Jan 2025
- Phase
- Observational
- 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
Study population: In phase (1), all previously collected, anonymized and stored endoscopic images and videos of early GI neoplasia in the departmental endoscopy teaching and training library. In phase (2), all eligible patients coming for upper and/or lower GI endoscopy for clinical reasons in participating centres will be approached for enrolment into this study.
Who may be able to join
- -The participant must meet ALL of the following criteria to be considered eligible for the study:
- Male or Female, aged 18 years or above.
- Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Patients with endoscopically active severe oesophagitis
- Poor bowel preparation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS University Trust
Portsmouth, Hampshire, PO63LY
About this study
Official title: Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.
Read the detailed description
This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation \& Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis.
This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- collection of endoscopic images and videos
- Keywords
- gastrointestinal neoplasia, artificial intelligence
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of endoscopic images and videosOther
collection of endoscopic images and videos
What is being measured
The primary outcome is the main question the study is designed to answer.
neoplasia detection rate
neoplasia detection rate of the AI algorithms in different locations of the GI tract.
Measured: during the procedure, up to 24 weeks, at 1 year, through study completion
Secondary outcomes (2)
Accuracy of AI diagnosis
Accuracy of real time optical diagnosis (characterization) of GI neoplasia by the AI algorithm.
Measured: during the procedure, up to 24 weeks, at 1 year, through study completion
Endoscopist neoplasia detection rate
Detection rate of endoscopists at various levels of experience
Measured: during the procedure, up to 24 weeks, at 1 year, through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start16 Jun 2021
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, Prof, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937647
- Sponsor's protocol ID
- PHT/2020/58
- Acronym
- NEW-AGE
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2021
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
- ClinicalTrials.gov ID
- NCT04937647
- Acronym / sponsor ID
- NEW-AGE / PHT/2020/58
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- gastrointestinal neoplasia, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 24 Jun 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.
This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.
Detailed description
This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation \& Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis.
This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In phase (1), all previously collected, anonymized and stored endoscopic images and videos of early GI neoplasia in the departmental endoscopy teaching and training library. In phase (2), all eligible patients coming for upper and/or lower GI endoscopy for clinical reasons in participating centres will be approached for enrolment into this study.
Key inclusion criteria (4 listed)
- -The participant must meet ALL of the following criteria to be considered eligible for the study:
- Male or Female, aged 18 years or above.
- Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (3 listed)
- Patients with endoscopically active severe oesophagitis
- Poor bowel preparation
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 |
|---|---|---|
| collection of endoscopic images and videoscollection of endoscopic images and videos | Other | – |
Primary outcome
neoplasia detection rate
Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion
neoplasia detection rate of the AI algorithms in different locations of the GI tract.
2 secondary outcomes
Accuracy of AI diagnosis
Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion
Endoscopist neoplasia detection rate
Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion
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 17 Sep 2026.
- 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.
Pradeep Bhandari, Prof principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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 17 Sep 2026. 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 United Kingdom. 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?
neoplasia detection rate (time frame: during the procedure, up to 24 weeks, at 1 year, through study completion). 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 17 Sep 2026.