Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

November 5, 2023 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

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
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wearable magnet tracking system
Device: wearable magnet tracking system
In this group, wearable magnet tracking system was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of time
Time Frame: 12 months
the length of time of the tracking system used in continuous acquisition of the magnetic field strength values
12 months

Collaborators and Investigators

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

Sponsor

Qilu Hospital of 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)

March 30, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022SDU-QILU-827

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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