Elastography Interest in the Management of Thyroid Nodules (SWETHY)

AdministrateurCIC

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thyroid Nodules

Treatments: Device: Medical ultrasound device (ShearWave system)

Study type: Interventional

Funder types: Other

Identifiers

NCT01335828

DCIC 10 24

Details and patient eligibility

About

Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged over 18 years old
• Patient affiliated to social security or similarly regime
• Patients referred for fine needle aspiration or surgery with one or more thyroid nodules

Exclusion criteria

• Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data
• Patients withan echography/elastography indications cons
• Pregnant women and lactating mothers
• Adult unable to express their consent
• Ward of court or under guardianship
• Person under legal protection
• Person deprived of freedom by judicial or administrative decision
• Person hospitalized without their consent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 1 patient group

echography/elastography

Other group

Treatment:

Device: Medical ultrasound device (ShearWave system)