AzTrials
AzTrials

Upper Gastrointestinal SymptomsNCT05832411

Effect of AI Monitoring Blind Spots of EGD on the Inspection Time and Lesion Dection Rate

A study testing Endoangle in people with Upper Gastrointestinal Symptoms, run by Renmin Hospital of Wuhan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The goal of this clinic trial is to learn about the effect of AI monitoring blind spots on the inspection time to EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Upper Gastrointestinal Symptoms
What is being tested?
Endoangle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,672 participants
Where
No sites listed yet
Study dates
1 Jul 2023to 31 Aug 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

  • patients aged 18 years or older
  • patients able to give informed consent
  • American Society of Anesthesiology risk class 1,2 or 3

Who cannot join

  • patients with absolute contraindications to EGD examination
  • patients with a history of previous gastrectomy
  • patients with a serious underlying disease
  • pregnant patients
  • researchers believe that the patient is not suitable to participate in the trial

About this study

Official title: Effect of Artificial Intelligence Monitoring Blind Spots of EGD on the Inspection Time and Dection Rate of Neoplastic Lesions

The goal of this clinic trial is to learn about the effect of AI monitoring blind spots on the inspection time to EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. In the AI group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. Researchers will compare intervention group to see if it have a shorter inspection time compared with the control group.

Read the detailed description

The goal of this clinic trial is to evaluate the effect of real-time artificial intelligence for monitoring blind spots on the inspection time of EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. In the AI group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. Researchers will compare intervention group to see if it have a shorter inspection time in the case of non-inferior detection rate of gastric neoplastic lesions.

Being tested
Endoangle
Keywords
Esophagogastroduodenoscopy, Artificial intelligence, Blind spot
Medical subject headings
Scotoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoangleDevice

    there is additional information presented to endoscopists:（1）the virtual stomach model monitoring；（2）time;（3）scoring.

Study groups in NCT05832411
Study groupRoleWhat they receive
AI groupExperimentalIn the AI group, except for the original videos, there is additional information presented to endoscopists:（1）the virtual stomach model monitoring;（2）time;（3）scoring. Endoscopists will complete EGD examination without blind spots.
Receives: Device: Endoangle
Routine groupNo interventionIn the Routine group, only the original videos and there is no additional information, and inspection time will be no less than 7 minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dection rate of neoplastic lesions

    Proportion of patients with neoplastic lesions among all patients undergoing esophagogastroduodenoscopy.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (1)

  1. Inspection time

    It is the time from intubation to extubation of the patient without biopsy.

    Measured: 20min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,672 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832411
Sponsor's protocol ID
EA-23-005
Status last verified
Mar 2023
First submitted
3 Apr 2023
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sponsor approval for data sharing should be sought; Data access requests should be made via an application form detailing the specific requirements and the proposed research and publication plan

Publications

  • Wu L, Zhang J, Zhou W, An P, Shen L, Liu J, Jiang X, Huang X, Mu G, Wan X, Lv X, Gao J, Cui N, Hu S, Chen Y, Hu X, Li J, Chen D, Gong D, He X, Ding Q, Zhu X, Li S, Wei X, Li X, Wang X, Zhou J, Zhang M, Yu HG. Randomised controlled trial of WISENSE, a real-time quality improving system for monitoring blind spots during esophagogastroduodenoscopy. Gut. 2019 Dec;68(12):2161-2169. doi: 10.1136/gutjnl-2018-317366. Epub 2019 Mar 11.

    PubMed 30858305

  • Wu L, Xu M, Jiang X, He X, Zhang H, Ai Y, Tong Q, Lv P, Lu B, Guo M, Huang M, Ye L, Shen L, Yu H. Real-time artificial intelligence for detecting focal lesions and diagnosing neoplasms of the stomach by white-light endoscopy (with videos). Gastrointest Endosc. 2022 Feb;95(2):269-280.e6. doi: 10.1016/j.gie.2021.09.017. Epub 2021 Sep 20.

    PubMed 34547254

  • Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.

    PubMed 27548885

  • Tan X, Yao L, Dong Z, Li Y, Yu Y, Gao X, Zhu K, Su W, Yin H, Wang W, Luo C, Li J, You H, Hu H, Zhou W, Yu H. Artificial Intelligence as a Surrogate for Inspection Time to Assess Completeness in Esophagogastroduodenoscopy: A Prospective, Randomized, Noninferiority Study. Clin Transl Gastroenterol. 2025 Mar 25;16(6):e00839. doi: 10.14309/ctg.0000000000000839. eCollection 2025 Jun 1.

    PubMed 40125855

Questions about this trial

What is this clinical trial studying?

A study testing Endoangle in people with Upper Gastrointestinal Symptoms, run by Renmin Hospital of Wuhan University.

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 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Dection rate of neoplastic lesions (time frame: Through study completion, an average of 1 year). 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 NCT05832411, which also lists 4 linked publications.

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 22 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in