Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

Capsule Endoscopes Clinical Trial

Official title:

Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546346
• Other study ID #: 2022SDU-QILU-827
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: Qilu Hospital of Shandong University
• Contact: Jingran Su, PhD
• Phone: 18769787193
• Email: taylor1943[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Endoscopes

Intervention

Device:
• wearable magnet tracking system
In this group, wearable magnet tracking system was used.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of time	the length of time of the tracking system used in continuous acquisition of the magnetic field strength values	12 months