One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy
23. juni 2026 opdateret af: Yanqing Li, Shandong University
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
93
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rui Ji, MD PHD
- Telefonnummer: +86-18560086103
- E-mail: qljirui@email.sdu.edu.cn
Studiesteder
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Shandong
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Jinan, Shandong, Kina, 250012
- Qilu Hospital of Shandong University
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Kontakt:
- Rui Ji, MD PHD
- Telefonnummer: +86-18560086103
- E-mail: qljirui@email.sdu.edu.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: One-Click Autofocus followed by Segmented Focus
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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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.
|
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Aktiv komparator: Segmented Focus followed by One-Click Autofocus
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Image Quality Quantification by Edge Detection Analysis
Tidsramme: Day 1 (During the endoscopic examination)
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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.
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Day 1 (During the endoscopic examination)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective Image Quality Assessment by Blinded Expert Review
Tidsramme: Day 1 (During the endoscopic examination)
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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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Day 1 (During the endoscopic examination)
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Image Acquisition Time per Capture
Tidsramme: Day 1 (During the endoscopic examination)
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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.
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Day 1 (During the endoscopic examination)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
18. juni 2026
Primær færdiggørelse (Anslået)
31. juli 2026
Studieafslutning (Anslået)
15. august 2026
Datoer for studieregistrering
Først indsendt
17. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KYLL-2026-01(YJ)-072
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