An interventional study of One-Click Autofocus and Segmented Focus in Stomach Neoplasms and Stomach Diseases, sponsored by Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Shandong University · Not applicable, Interventional, and Diagnostic
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 93 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: One-Click Autofocus · Procedure: Segmented Focus
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.
Procedure: One-Click Autofocus · Procedure: Segmented Focus
Magnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press.
Magnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes.
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.
Time frame: Day 1 (During the endoscopic examination)
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.
Time frame: 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.
Time frame: Day 1 (During the endoscopic examination)
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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