Recruiting

Radiofrequency Ablation

Sponsor:

University Health Network, Toronto

Code:

NCT06929650

Conditions

Thyroid Nodule

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Radiofrequency ablation

Study Details

Brief summary:

The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is:

• What is the feasibility of RFA use for low-risk thyroid cancers (≤2 cm)?

Participants will undergo a set of pre-procedural scans of the target thyroid nodule and undergo the RFA procedure/intervention. Then, participants will partake in three follow-up appointments at 4 weeks, 6 months, and 12 months post-procedure as per standard of care.

Conditions

Thyroid Nodule

Thyroid Cancer

Study ID

NCT06929650

Start date

Apr 20, 2023

Status verified date

Apr, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients with:

  • Nodule less than or equal to 2cm in size

a. Specifically: Bethesda 5/6
  • Their age is ≥18 years and ≤100 years
  • Able to provide written consent
  • Able to attend required follow-ups as per the protocol

Exclusion Criteria:

  • Patients <18 years old
  • Pregnant women
  • Any concern for invasive or metastatic thyroid cancer
  • Previously treated for thyroid cancer

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Participants receive RFA intervention for thyroid nodule.

Interventions

Radiofrequency ablation

Radiofrequency energy is delivered to the thyroid nodule via the medical device. This device is a system consisting of 3 main components:

1. VIVA combo RF system (generator and pump)
2. single foot switch
3. electrode (5mm, 7mm, 10mm, or adjustable).

Primary outcome measure

  • Complications [ Time Frame: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure. ]

Central Contacts and Locations

Central contacts

Jesse Pasternak

(416) 340-4792jesse.pasternak@uhn.ca

Emily Saso

emily.saso@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Ilhaan Abdulle

(416) 340-4792ilhaan.abdulle@uhn.ca

Emily Saso

(613) 854-4420emily.saso@uhn.ca

Principal Investigator:

Jesse D Pasternak, MD, MPH

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Keywords

  • Radiofrequency Ablation
  • Feasibility
  • Adverse Event
  • Thyroid nodule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-04-16.