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Not yet recruiting NCT07664813

One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy

No phase Interventional Stomach Neoplasms Stomach Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One-Click Autofocus, Segmented Focus.
Who it may be relevant to
Registry conditions: Stomach Neoplasms, Stomach Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study of One-Click Autofocus Versus Segmented Focus Techniques Under Magnifying Endoscopy for Gastric Diseases: A Tandem Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure One-Click Autofocus
    Magnifying endoscopy examination performed using the one-click autofocus mode. The system automatically adjusts focus to the optimal plane with a single button press.
  • Procedure Segmented Focus
    Magnifying endoscopy examination performed using the segmented focus mode. The endoscopist manually adjusts the focus level stepwise through multiple pre-set focal planes.

Primary outcome measures

  • Image Quality Quantification by Edge Detection Analysis [Time frame: Day 1 (During the endoscopic examination)]
Secondary outcome measures (2)
  • Subjective Image Quality Assessment by Blinded Expert Review [Time frame: Day 1 (During the endoscopic examination)]
  • Image Acquisition Time per Capture [Time frame: Day 1 (During the endoscopic examination)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07664813 · KYLL-2026-01(YJ)-072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗