Stomach NeoplasmsNCT07664813
One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy
A study testing One-Click Autofocus and Segmented Focus in people with Stomach Neoplasms and Stomach Diseases, run by Shandong University at 1 site in China.
Trial summary
Magnifying endoscopy provides high-resolution images that enhance the detection of early gastrointestinal lesions. However, conventional manual zoom techniques require frequent focal adjustments, which can be technically demanding and may compromise image stability, especially in complex anatomical settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Stomach Diseases
- What is being tested?
- One-Click Autofocus and Segmented Focus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients with gastric diseases (e.g., suspicious lesions, known gastric disorders) requiring further magnifying endoscopy examination
- Ability to understand and provide written informed consent voluntarily
Who cannot join
- Absolute contraindications to upper gastrointestinal endoscopy (e.g., severe cardiopulmonary insufficiency, coagulopathy)
- Pregnant or lactating women
- History of gastric surgery (e.g., gastrectomy) that may affect endoscopic manipulation or anatomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Rui Ji, MD PHD, +86-18560086103, qljirui@email.sdu.edu.cn
About this study
Official title: A Comparative Study of One-Click Autofocus Versus Segmented Focus Techniques Under Magnifying Endoscopy for Gastric Diseases: A Tandem Randomized Controlled Trial
Magnifying endoscopy provides high-resolution images that enhance the detection of early gastrointestinal lesions. However, conventional manual zoom techniques require frequent focal adjustments, which can be technically demanding and may compromise image stability, especially in complex anatomical settings.
This study evaluates a novel one-click autofocus system based on image recognition and computer vision algorithms. The system automatically adjusts focal distance within seconds, eliminating the need for manual operation. This trial aims to compare the efficiency and image quality of one-click autofocus versus segmented manual focus in patients undergoing magnifying endoscopy for gastric diseases.
A tandem randomized controlled trial will be conducted to assess procedure time, image clarity score, and operator satisfaction between the two techniques.
- Conditions
- Stomach Neoplasms, Stomach Diseases
- Being tested
- One-Click Autofocus, Segmented Focus
- Keywords
- Magnifying Endoscopy, Gastroscopy, One-Click Autofocus, Segmented Focus, Image Quality
- Medical subject headings
- Stomach Neoplasms, Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Click AutofocusProcedure or surgery
Magnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press.
Segmented FocusProcedure or surgery
Magnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes.
| Study group | Role | What they receive |
|---|---|---|
| One-Click Autofocus followed by Segmented Focus | Experimental | Participants receive one-click autofocus examination first, followed by segmented focus examination. Both examinations are performed during the same endoscopic session. The order of the two techniques is randomized. Receives: Procedure: One-Click Autofocus; Procedure: Segmented Focus |
| Segmented Focus followed by One-Click Autofocus | Active comparator | Participants receive segmented focus examination first, followed by one-click autofocus examination. Both examinations are performed during the same endoscopic session. The order of the two techniques is randomized. Receives: Procedure: One-Click Autofocus; Procedure: Segmented Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality Quantification by Edge Detection Analysis
Image quality is objectively quantified using edge detection analysis applied to standardized images captured by each technique. The standard deviation of pixel intensity after edge detection processing is used as the quantitative metric. A higher standard deviation indicates higher image contrast and edge definition, reflecting superior image quality. All image analyses are performed offline by an independent researcher blinded to the technique used.
Measured: Day 1 (During the endoscopic examination)
Secondary outcomes (2)
Subjective Image Quality Assessment by Blinded Expert Review
Image quality is subjectively assessed by two to three independent expert reviewers blinded to the technique used. Recorded videos of magnifying endoscopy examinations are reviewed offline and scored using a 5-point Likert scale, where 1 = poor and 5 = excellent. Higher scores indicate superior image quality. The final score for each image is the average of the reviewers' scores.
Measured: Day 1 (During the endoscopic examination)
Image Acquisition Time per Capture
Time (in seconds) measured for each image acquisition, defined as the duration from the moment the endoscope makes contact with the target gastric mucosa to the capture of the final magnified image for each technique.
Measured: Day 1 (During the endoscopic examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664813
- Sponsor's protocol ID
- KYLL-2026-01(YJ)-072
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of One-Click Autofocus Versus Segmented Focus Techniques Under Magnifying Endoscopy for Gastric Diseases: A Tandem Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07664813
- Acronym / sponsor ID
- KYLL-2026-01(YJ)-072
- Conditions
- Stomach Neoplasms, Stomach Diseases
- Keywords
- Magnifying Endoscopy, Gastroscopy, One-Click Autofocus, Segmented Focus, Image Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 24 Jun 2026 (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.
Magnifying endoscopy provides high-resolution images that enhance the detection of early gastrointestinal lesions. However, conventional manual zoom techniques require frequent focal adjustments, which can be technically demanding and may compromise image stability, especially in complex anatomical settings.
This study evaluates a novel one-click autofocus system based on image recognition and computer vision algorithms. The system automatically adjusts focal distance within seconds, eliminating the need for manual operation. This trial aims to compare the efficiency and image quality of one-click autofocus versus segmented manual focus in patients undergoing magnifying endoscopy for gastric diseases.
A tandem randomized controlled trial will be conducted to assess procedure time, image clarity score, and operator satisfaction between the two techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-Click Autofocus followed by Segmented Focus | Experimental | Procedure: One-Click Autofocus, Procedure: Segmented FocusParticipants receive one-click autofocus examination first, followed by segmented focus examination. Both examinations are performed during the same endoscopic session. The order of the two techniques is randomized. |
| Segmented Focus followed by One-Click Autofocus | Active comparator | Procedure: One-Click Autofocus, Procedure: Segmented FocusParticipants receive segmented focus examination first, followed by one-click autofocus examination. Both examinations are performed during the same endoscopic session. The order of the two techniques is randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with gastric diseases (e.g., suspicious lesions, known gastric disorders) requiring further magnifying endoscopy examination
- Ability to understand and provide written informed consent voluntarily
Key exclusion criteria (3 listed)
- Absolute contraindications to upper gastrointestinal endoscopy (e.g., severe cardiopulmonary insufficiency, coagulopathy)
- Pregnant or lactating women
- History of gastric surgery (e.g., gastrectomy) that may affect endoscopic manipulation or anatomy
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 |
|---|---|---|
| One-Click AutofocusMagnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press. | Procedure or surgery | One-Click Autofocus followed by Segmented Focus, Segmented Focus followed by One-Click Autofocus |
| Segmented FocusMagnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes. | Procedure or surgery | One-Click Autofocus followed by Segmented Focus, Segmented Focus followed by One-Click Autofocus |
Primary outcome
Image Quality Quantification by Edge Detection Analysis
Time frame: Day 1 (During the endoscopic examination)
Image quality is objectively quantified using edge detection analysis applied to standardized images captured by each technique. The standard deviation of pixel intensity after edge detection processing is used as the quantitative metric. A higher standard deviation indicates higher image contrast and edge definition, reflecting superior image quality. All image analyses are performed offline by an independent researcher blinded to the technique used.
2 secondary outcomes
Subjective Image Quality Assessment by Blinded Expert Review
Time frame: Day 1 (During the endoscopic examination)
Image Acquisition Time per Capture
Time frame: Day 1 (During the endoscopic examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Click Autofocus and Segmented Focus in people with Stomach Neoplasms and Stomach Diseases, run by Shandong University at 1 site in China.
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: opening soon, as of the sponsor's last update on 24 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Ji, MD PHD (+86-18560086103, qljirui@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality Quantification by Edge Detection Analysis (time frame: Day 1 (During the endoscopic examination)). 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 24 Jun 2026.