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

January 7, 2026 updated by: Xiuli Zuo, Shandong University

Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capsule endoscope's responsiveness to the attitude controller
Time Frame: During performing double-balloon enteroscope

Excellent: The magnetically controlled capsule endoscope can precisely follow the attitude controller to move to the target area.

Moderate: The magnetically controlled capsule endoscope can follow the attitude controller's movement, but cannot be accurately guided to the target area.

Poor: There are signs of magnetic attraction, but the capsule does not follow the movement of the attitude controller.
During performing double-balloon enteroscope

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KYLL-2025-10-008-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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