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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Click Autofocus | Procedure | Magnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (During the endoscopic examination) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Ji, MD PHD | Contact | +86-18560086103 | qljirui@email.sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Segmented Focus | Procedure | Magnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes. |
|
| 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. | Day 1 (During the endoscopic examination) |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |