One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy
23 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
93
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Rui Ji, MD PHD
- Telefonnummer: +86-18560086103
- E-post: qljirui@email.sdu.edu.cn
Studieorter
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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-post: qljirui@email.sdu.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Image Quality Quantification by Edge Detection Analysis
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Subjective Image Quality Assessment by Blinded Expert Review
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
18 juni 2026
Primärt slutförande (Beräknad)
31 juli 2026
Avslutad studie (Beräknad)
15 augusti 2026
Studieregistreringsdatum
Först inskickad
17 juni 2026
Först inskickad som uppfyllde QC-kriterierna
23 juni 2026
Första postat (Faktisk)
24 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KYLL-2026-01(YJ)-072
Läkemedels- och apparatinformation, studiedokument
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