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Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes

S

Shandong University

Status

Enrolling

Conditions

Capsule Endoscopes

Treatments

Device: wearable magnet tracking system

Study type

Interventional

Funder types

Other

Identifiers

NCT05546346
2022SDU-QILU-827

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

wearable magnet tracking system
Experimental group
Treatment:
Device: wearable magnet tracking system

Trial contacts and locations

1

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Central trial contact

Jingran Su, PhD

Data sourced from clinicaltrials.gov

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