NCT05546346

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

September 15, 2022

Last Update Submit

October 16, 2024

Conditions

Capsule Endoscopes

Outcome Measures

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

    12 months

Study Arms (1)

wearable magnet tracking system

EXPERIMENTAL
Device: wearable magnet tracking system

Interventions

wearable magnet tracking systemDEVICE

In this group, wearable magnet tracking system was used.

wearable magnet tracking system

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • currently participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Central Study Contacts

Jingran Su, PhD

CONTACT

18769787193taylor1943@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

March 30, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

CN(1)