Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05546346

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Capsule Endoscopes	Device: wearable magnet tracking system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: wearable magnet tracking system

Device: wearable magnet tracking system

In this group, wearable magnet tracking system was used.

Outcome Measures

Primary Outcome Measures

The duration of time [12 months]
the length of time of the tracking system used in continuous acquisition of the magnetic field strength values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qilu Hospital of Shandong University	Jinan	Shandong	China

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qilu Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT05546346

Other Study ID Numbers:

2022SDU-QILU-827

First Posted:

Sep 19, 2022

Last Update Posted:

Sep 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 22, 2022