Hyperthyroidism, Hyperthyroidism; Goiter, Multinodular Goiter, Thyroid Disease, Thyroid Nodules, Toxic Multinodular Goiter
Conditions
Keywords
PED-TAE, TriNav Infusion System, Thyroid artery embolization
Brief summary
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.
Interventions
OTHERData Collection
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.
Sponsors
TriSalus Life Sciences, Inc.
Sarasota Memorial Health Care System
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Adults, 18 years and or older and 89 years or younger 2. Having undergone PED-TAE using the TriNav Infusion System 3. Meeting one of the following criteria: 1. Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule \> 20 ml 2. Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation 3. 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 4. 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
1. Renal insufficiency 2. Unable to tolerate angiography including pregnancy and severe allergy to contrast media 3. Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant) 4. \<18 years old or \>89 years old 5. Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography 6. Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present 7. Prior thyroid thermal ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ThyPro-39 questionnaire | 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. |
| Procedure related adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Thyroid volume change | 6 months | Thyroid volume change based on 3D CT volumetry at 6-months (+/- 60 days) post-treatment |
| Change in TSH, T3 and T4 | 6 months | Change in TSH, T3 and T4 levels at 2-weeks (+/- 7 days), 3-(+/- 30 days) and 6-months (+/- 60 days) post-treatment |
Countries
United States
Outcome results
None listed