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NCT Number: NCT07664813

One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy

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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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Image Quality Quantification by Edge Detection Analysis

    Time frame: Day 1 (During the endoscopic examination)

    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.

Secondary outcomes

  1. Subjective Image Quality Assessment by Blinded Expert Review

    Time frame: Day 1 (During the endoscopic examination)

    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.

  2. Image Acquisition Time per Capture

    Time frame: Day 1 (During the endoscopic examination)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Ji, MD PHD

CONTACT

[email protected]

+86-18560086103

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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