One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
One-Click Autofocus
Procedure/SurgeryMagnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press.
Segmented Focus
Procedure/SurgeryMagnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes.
Treatment groups
93 Participants
are divided into 2 treatment groupsGroup A: One-Click Autofocus followed by Segmented FocusExperimental treatment 2 interventions
Group B: Segmented Focus followed by One-Click AutofocusActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Qilu Hospital of Shandong University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: