RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University

About this trial

The purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (MNG) patients. This is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients >/=18 years old with benign thyroid nodules

Disqualifiers

cardiac arrhythmia

pregnancy

Trial population

Adult patients (\>/=18 years) with benign, non-functional benign thyroid nodules

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Thyroidectomy

    Procedure/Surgery

    Surgical Resection of thyroid nodules

  • Radiofrequency Ablation

    Device

    Radiofrequency Ablation of thyroid nodules

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Thyroidectomy1 intervention
Group B: RFA1 intervention

Trial outcomes

Primary outcomes

1

Percent Volume Change of Nodules

Percent Volume Change of Nodules: ((Volume (baseline) - Volume (\*m\*))/Volume(baseline))\*100

Time frame
6 months and 12 months
2

Change in Thyroid Stimulating Hormone (TSH)

Change in serum TSH

Time frame
6 months and 12 months
3

ThyPRO 39 Survey Score

The Thypro 39 is a survey assessing quality of life in patients with thyroid disease. Scores range from 0-100 with a higher score indicating a worse outcome.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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