Barrett EsophagusNCT05628441
Real-time Computer Aided Detection of Barrett's Neoplasia
An observational study of Barrett Esophagus and Barrett Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Barrett Adenocarcinoma
- What is being tested?
- Computer Aided Detection system for Barrett's neoplasia
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 May 2022to 13 Oct 2022
- How long will I take part?
- 1 Day
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Barrett's esophagus, either receiving a surveillance endoscopy according to protocol or referred for endoscopic treatment for proven neoplasia in their Barrett's esophagus
Who may be able to join
- Age > 18 years;
- Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;
- A circumferential Barrett length of at least 2cm
Who cannot join
- Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus
- Reflux esophagitis > grade 2 (LA classification)
- Inability to undergo endoscopic treatment and/or biopsies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
Read the detailed description
Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).
Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.
During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.
- Conditions
- Barrett Esophagus, Barrett Adenocarcinoma
- Being tested
- Computer Aided Detection system for Barrett's neoplasia
- Keywords
- Barrett's Esophagus, Computer Aided Detection
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided Detection system for Barrett's neoplasiaOther
CADe system running in the back, not directly interfering with patient care
| Study group | Role | What they receive |
|---|---|---|
| CADe system | All patients included in the study will undergo the endoscopic procedure according to standard clinical care and the study protocol. The CADe system will run in the back, not interfering with care. Receives: Other: Computer Aided Detection system for Barrett's neoplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
To investigate the combined performance between endoscopist and CADe system on a per-patient level.
Measured: 5 months
Secondary outcomes (1)
Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity
To investigate the performance of the CADe system on new data on a per-patient level.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start16 May 2022
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
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 Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. J.J.G.H.M. Bergman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- J.J. Bergman, MD PHD, Principal investigator, Amsterdam University Medical Centers, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628441
- Sponsor's protocol ID
- 2021.0269
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Publications
Fockens KN, Jukema JB, Jong MR, Boers T, van der Putten JA, Kusters CHJ, Pouw RE, Duits LC, van der Sommen F, de With PH, de Groof AJ, Bergman JJ; BONS-AI consortium. The use of a real-time computer-aided detection system for visible lesions in the Barrett's esophagus during live endoscopic procedures: a pilot study (with video). Gastrointest Endosc. 2024 Sep;100(3):527-531.e3. doi: 10.1016/j.gie.2024.04.011. Epub 2024 Apr 9.
PubMed 38604297
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study
- ClinicalTrials.gov ID
- NCT05628441
- Acronym / sponsor ID
- 2021.0269
- Conditions
- Barrett Esophagus, Barrett Adenocarcinoma
- Keywords
- Barrett's Esophagus, Computer Aided Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 28 Nov 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.
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
Detailed description
Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).
Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.
During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CADe system | – | Other: Computer Aided Detection system for Barrett's neoplasiaAll patients included in the study will undergo the endoscopic procedure according to standard clinical care and the study protocol. The CADe system will run in the back, not interfering with care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Barrett's esophagus, either receiving a surveillance endoscopy according to protocol or referred for endoscopic treatment for proven neoplasia in their Barrett's esophagus
Key inclusion criteria (3 listed)
- Age > 18 years;
- Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;
- A circumferential Barrett length of at least 2cm
Key exclusion criteria (3 listed)
- Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus
- Reflux esophagitis > grade 2 (LA classification)
- Inability to undergo endoscopic treatment and/or biopsies
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 |
|---|---|---|
| Computer Aided Detection system for Barrett's neoplasiaCADe system running in the back, not directly interfering with patient care | Other | CADe system |
Primary outcome
Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
Time frame: 5 months
To investigate the combined performance between endoscopist and CADe system on a per-patient level.
1 secondary outcome
Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity
Time frame: 5 months
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 28 Nov 2022.
- Derived from this study: PubMed 38604297Fockens KN, Jukema JB, Jong MR, Boers T, van der Putten JA, Kusters CHJ, Pouw RE, Duits LC, van der Sommen F, de With PH, de Groof AJ, Bergman JJ; BONS-AI consortium. The use of a real-time computer-aided detection system for visible lesions in the Barrett's esophagus during live endoscopic procedures: a pilot study (with video). Gastrointest Endosc. 2024 Sep;100(3):527-531.e3. doi: 10.1016/j.gie.2024.04.011. Epub 2024 Apr 9.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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.
J.J. Bergman, MD PHD principal investigator
Amsterdam University Medical Centers, location AMC
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 Barrett Esophagus and Barrett Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 3 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 28 Nov 2022. 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?
Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity (time frame: 5 months). 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 NCT05628441, 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 28 Nov 2022.