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Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules

NCT04879355 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-07-05

No results posted yet for this study

Summary

This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.

Conditions

  • Thyroid Nodule

Interventions

DEVICE

Spinal needle (25G)

Fine needle aspiration from thyroid nodules using a 25G spinal needle.

DEVICE

Conventional fine needle (25G)

Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Preben Homøe

    lead OTHER

Principal Investigators

  • Tobias Andersen, MD · Zealand University Hospital, Køge, Denmark.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-05-01
Completion
2023-11-01

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879355 on ClinicalTrials.gov