Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
NCT ID: NCT06868459
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2025-04-01
2028-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Thyroid Artery Goitre Embolization Trial A Pilot Study Investigating Thyroid Artery Embolisation as a Treatment for Large Thyroid Nodules
NCT07046546
Role of Embolization of Thyroid Arteries as a Treatment for Different Thyroid Disorders
NCT06537141
Therapeutic Plasma Exchange in Thyrotoxicosis
NCT04485975
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
NCT03461211
Desiccated Thyroid Extract Versus Synthetic T3/T4 Combination (ThyrolarTM) Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism
NCT02317926
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients who have undergone PED-TAE using the TriNav Infusion System at participating study sites.
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.
Data 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Data 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TriSalus Life Sciences, Inc.
INDUSTRY
Sarasota Memorial Health Care System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan C. Camacho, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tamela Fonseca, PhD, RN, CCRC, NE-BC
Role: STUDY_DIRECTOR
Sarasota Memorial Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yilmaz 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.
Wiener 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.
Watt 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.
Sjolin 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.
Russell 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.
Roque 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.
Paschke 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.
Moon JH, Hyun MK, Lee JY, Shim JI, Kim TH, Choi HS, Ahn HY, Kim KW, Park DJ, Park YJ, Yi KH. Prevalence of thyroid nodules and their associated clinical parameters: a large-scale, multicenter-based health checkup study. Korean J Intern Med. 2018 Jul;33(4):753-762. doi: 10.3904/kjim.2015.273. Epub 2017 Jul 7.
Elte JW, Bussemaker JK, Haak A. The natural history of euthyroid multinodular goitre. Postgrad Med J. 1990 Mar;66(773):186-90. doi: 10.1136/pgmj.66.773.186.
Dean DS, Gharib H. Epidemiology of thyroid nodules. Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):901-11. doi: 10.1016/j.beem.2008.09.019.
Cheng KL, Liang KW, Lee HL, Wang HY, Shen CY. Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach. Quant Imaging Med Surg. 2023 Aug 1;13(8):5355-5361. doi: 10.21037/qims-22-1385. Epub 2023 May 30.
Campenni A, Avram AM, Verburg FA, Iakovou I, Hanscheid H, de Keizer B, Petranovic Ovcaricek P, Giovanella L. The EANM guideline on radioiodine therapy of benign thyroid disease. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3324-3348. doi: 10.1007/s00259-023-06274-5. Epub 2023 Jul 3.
Berghout A, Wiersinga WM, Smits NJ, Touber JL. Interrelationships between age, thyroid volume, thyroid nodularity, and thyroid function in patients with sporadic nontoxic goiter. Am J Med. 1990 Nov;89(5):602-8. doi: 10.1016/0002-9343(90)90178-g.
Bahre M, Hilgers R, Lindemann C, Emrich D. Thyroid autonomy: sensitive detection in vivo and estimation of its functional relevance using quantified high-resolution scintigraphy. Acta Endocrinol (Copenh). 1988 Feb;117(2):145-53. doi: 10.1530/acta.0.1170145.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-ENT-97
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.