One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy

NCT07664813 | Not Yet Recruiting

• 1 other identifier: KYLL-2026-01(YJ)-072
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stomach Neoplasms; Stomach Diseases

Keywords

Magnifying Endoscopy; Gastroscopy; One-Click Autofocus; Segmented Focus; Image Quality

Outcome Measures

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.

  Day 1 (During the endoscopic examination)

Secondary Outcomes (2)

• Subjective Image Quality Assessment by Blinded Expert Review

  Day 1 (During the endoscopic examination)

• Image Acquisition Time per Capture

  Day 1 (During the endoscopic examination)

Study Arms (2)

One-Click Autofocus followed by Segmented Focus

EXPERIMENTAL

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.

Procedure: One-Click Autofocus; Procedure: Segmented Focus

Segmented Focus followed by One-Click Autofocus

ACTIVE COMPARATOR

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.

Procedure: One-Click Autofocus; Procedure: Segmented Focus

Interventions

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.

One-Click Autofocus followed by Segmented Focus; Segmented Focus followed by One-Click Autofocus

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.

One-Click Autofocus followed by Segmented Focus; Segmented Focus followed by One-Click Autofocus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Rui Ji, MD PHD

CONTACT

+86-18560086103; qljirui@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: June 18, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

CN (1)