NCT04811677

Brief Summary

To approval for detecting lymphedema fibrosis before its progression, verification of CT-based quantification of suprafascial microscopic fibrosis has been tried.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

March 19, 2021

Last Update Submit

December 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy

    a ratio between the correctly classified pixel and all the classified pixel in one label.

    within 1 week after CT scanning

Secondary Outcomes (1)

  • First index

    within 1 week after CT scanning

Interventions

image analysis

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who were clinically diagnosed with limb lymphedema.

You may qualify if:

  • The patients who were clinically diagnosed with unilateral limb lymphedema and who underwent multi-frequency bio-electric impedance (BEI) analysis and CT scanning.

You may not qualify if:

  • The patients who were diagnosed with deep vein thrombosis, bilateral limbs involvement, vascular diseases or local infection were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Sejong Hospital

Sejong, 30099, South Korea

Location

MeSH Terms

Conditions

Lymphedema

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Chang Ho Hwang

    Chungnam National University Sejong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief director

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

January 1, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations