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RecruitingNCT05546346Updated Oct 18, 2024

Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

An interventional study of wearable magnet tracking system in Capsule Endoscopes, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The investigators developed a wearable magnet tracking system, which provided a non-invasive and high accuracy method for capsule endoscopes localization. Data fusion from multiple sensors expanded positioning range and proposed localization algorithm overcame shortcomings of existing systems. This clinical trial was conducted to verify effectiveness and stability of the tracking system.

02

Conditions studied

  • Capsule Endoscopes
03

In context

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged between 18 and 75
  • agree to give written informed consent

Exclusion criteria

Exclusion Criteria:

  • dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation
  • congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, or artificial heart valves
  • pregnancy or suspected pregnancy
  • exclusion criteria for standard magnetic resonance imaging examination such as the presence of surgical metallic devices, even though its low magnetic field technically would not interferewith such devices
  • currently participating in another clinical study
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    wearable magnet tracking system

    Device: wearable magnet tracking system

Interventions

  • Devicewearable magnet tracking system

    In this group, wearable magnet tracking system was used.

06

What researchers measure

Primary outcomes

  1. The duration of time

    the length of time of the tracking system used in continuous acquisition of the magnetic field strength values

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05546346
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
Sep 19, 2022
Start date
Mar 30, 2023
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Oct 18, 2024

Study contacts

Jingran Su, PhD
Contact
taylor1943@163.com
18769787193

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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