NCT04457375

Brief Summary

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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 16, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 30, 2020

Last Update Submit

June 7, 2021

Conditions

Lymphedema, Secondary

Keywords

tissue dielectric constanthead and neck lymphedemalymphedemareference values

Outcome Measures

Primary Outcomes (2)

  • Neck-to-Arm TDC ratio

    Neck-to-Arm TDC ratio

    one year

  • Sub-Mental-to-Arm TDC ratio

    Sub-Mental-to-Arm TDC ratio

    one year

Secondary Outcomes (1)

  • Bilateral values and Variability in TDC values

    one year

Study Arms (1)

Healthy Adults

Healthy

Diagnostic Test: TDC

Interventions

TDCDIAGNOSTIC_TEST

measurements

Healthy Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • Healthy with no current or past skin conditions affecting neck or arms

You may not qualify if:

  • Known to have diabetes of any type.
  • Having facial or neck hair that prohibits accurate measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

MeSH Terms

Conditions

LymphedemaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

January 16, 2020

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations

US(1)