Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study

NCT ID: NCT07325344

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-31

Brief Summary

The aim of this study is to evaluate the responsiveness of the capsule endoscope to the attitude controller and to investigate its active locomotion performance within the small bowel.

Detailed Description

During the standard air insufflation or water infusion phases of double-balloon enteroscopy, researchers will use a handheld controller to try to steer the capsule. At the same time, the real-time imaging from both the enteroscope and the capsule will be simultaneously monitored to assess the capsule's active movement and its responsiveness to control.

Conditions

Capsule Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

subject

During the routine air/water insufflation phases of the enteroscopy, the researchers will attempt to guide the capsule's movement using an external magnetic control device.

Group Type: EXPERIMENTAL

magnetic control

Intervention Type: DEVICE

Intervention: On the day of the examination, the subject will swallow the capsule endoscope. This will be followed by a standard enteroscopy procedure. During the routine air/water insufflation phases of the enteroscopy, the researchers will attempt to guide the capsule's movement using an external magnetic control device.

Interventions

magnetic control

Intervention: On the day of the examination, the subject will swallow the capsule endoscope. This will be followed by a standard enteroscopy procedure. During the routine air/water insufflation phases of the enteroscopy, the researchers will attempt to guide the capsule's movement using an external magnetic control device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled to undergo enteroscopy.

Exclusion Criteria

• Patients with severe dysfunction of vital organs (e.g., heart, lungs). Patients with small bowel obstruction precluding adequate bowel preparation. Patients with a history of multiple abdominal surgeries. Patients with implanted devices such as cardiac pacemakers or metal implants. Patients with other high-risk conditions or lesions (e.g., moderate-to-severe esophagogastric varices, massive ascites).

Patients who are pregnant or lactating. Patients unable or unwilling to provide informed consent.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Director of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Zuo, MD,PhD

Role: CONTACT

zuoxiuli@sdu.edu.cn

+86-18560080066

Facility Contacts

Xiuli Zuo, MD, PhD

Role: primary

zuoxiuli@sdu.edu.cn

+86-18560080066

Other Identifiers

KYLL-2025-10-008-1

Identifier Type: -

Identifier Source: org_study_id