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Enrolling by Invitation

NCT Number: NCT06868459

Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.

Enrolling by Invitation

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, 18 years and or older and 89 years or younger
  • Having undergone PED-TAE using the TriNav Infusion System
  • Meeting one of the following criteria:
  • Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule > 20 ml
  • Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation
  • Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure symptoms
  • Bethesda category 2-3 (benign, or atypia or follicular lesion of undetermined significance) on 2 separate fine-needle aspiration biopsy (FNAB) results with a benign molecular profile with patient declining surgical resection

Exclusion criteria

  • Renal insufficiency
  • Unable to tolerate angiography including pregnancy and severe allergy to contrast media
  • Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
  • <18 years old or >89 years old
  • Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
  • Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
  • Prior thyroid thermal ablation

Treatment and study plan

Data Collection

Other

Subjects with planned PED-TAE delivered via TriNav will receive their treatment following routine standard of care procedures. Post-procedural data obtained by a patient chart review will be collected in a study database. No additional study-specific interventions or visits outside of the routine clinical treatment will be performed.

Primary outcomes

  1. ThyPro-39 questionnaire

    Time frame: 6 months

    Change in quality of life as measured by ThyPro-39 questionnaire at 6-months (+/- 60). Responses to each statement are measured on a Likert scale ranging from '0= no symptoms or problems' to '4= severe symptoms or problems' based on the period of the last 4 weeks. Higher scores indicate greater impact on quality of life due to thyroid issues.

  2. Procedure related adverse events

    Time frame: 6 months

    Safety as measured by the rate of procedure related adverse events as measured by SIR criteria at 2-weeks (+/- 7 days), 3- (+/- 30 days) and 6-months (+/- 60 days) post PED-TAE using TriNav treatment.

Secondary outcomes

  1. Thyroid volume change

    Time frame: 6 months

    Thyroid volume change based on 3D CT volumetry at 6-months (+/- 60 days) post-treatment

  2. Change in TSH, T3 and T4

    Time frame: 6 months

    Change in TSH, T3 and T4 levels at 2-weeks (+/- 7 days), 3-(+/- 30 days) and 6-months (+/- 60 days) post-treatment

Sponsors and collaborators

Lead sponsor

Sarasota Memorial Health Care System

Other

Collaborators

  • TriSalus Life Sciences, Inc.

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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