Clinical trial · Observational
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
NCT06868459CI-TRIAL-00094666enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperthyroidism | — | UNRESOLVED | — |
| Hyperthyroidism; Goiter | — | UNRESOLVED | — |
| Multinodular Goiter | — | UNRESOLVED | — |
| Thyroid Disease | — | UNRESOLVED | — |
| Thyroid Nodules | — | UNRESOLVED | — |
| Toxic Multinodular Goiter | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients who have undergone PED-TAE using the TriNav Infusion System at participating study sites.
- description
- 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.
- interventionNames
- Other: Data Collection
Primary outcomes (2)
- measure
- ThyPro-39 questionnaire
- timeFrame
- 6 months
- description
- 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.
- measure
- Procedure related adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (14)
- BACKGROUNDYilmaz S, Habibi HA, Yildiz A, Altunbas H. Thyroid Embolization for Nonsurgical Treatment of Nodular Goiter: A Single-Center Experience in 56 Consecutive Patients. J Vasc Interv Radiol. 2021 Oct;32(10):1449-1456. doi: 10.1016/j.jvir.2021.06.025. Epub 2021 Jul 10. PMID 34256121
- BACKGROUNDWiener JD, de Vries AA. On the natural history of Plummer's disease. Clin Nucl Med. 1979 May;4(5):181-90. doi: 10.1097/00003072-197905000-00002. PMID 582300
- BACKGROUNDWatt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8. PMID 25004246
- BACKGROUNDSjolin G, Watt T, Bystrom K, Calissendorff J, Cramon PK, Nystrom HF, Hallengren B, Holmberg M, Khamisi S, Lantz M, Planck T, Torring O, Wallin G. Long term outcome after toxic nodular goitre. Thyroid Res. 2022 Nov 1;15(1):20. doi: 10.1186/s13044-022-00138-0. PMID 36316779
- BACKGROUNDRussell JO, Desai DD, Noel JE, Hussein M, Toraih E, Seo S, Wolfe S, Omar M, Issa P, Orloff LA, Tufano RP, Kandil E. Radiofrequency ablation of benign thyroid nodules: A prospective, multi-institutional North American experience. Surgery. 2024 Jan;175(1):139-145. doi: 10.1016/j.surg.2023.07.046. Epub 2023 Nov 10. PMID 37953141
- BACKGROUNDRoque C, Santos FS, Pilli T, Dalmazio G, Castagna MG, Pacini F. Long-term Effects of Radioiodine in Toxic Multinodular Goiter: Thyroid Volume, Function, and Autoimmunity. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa214. doi: 10.1210/clinem/dgaa214. PMID 32320467
- BACKGROUNDPaschke R. Molecular pathogenesis of nodular goiter. Langenbecks Arch Surg. 2011 Dec;396(8):1127-36. doi: 10.1007/s00423-011-0788-5. Epub 2011 Apr 14.