NCT06868459Enrolling by invitation
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 5 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Sarasota Memorial Health Care System
- NCT number
- NCT06868459
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Apr 2025 to the primary completion date, 1 Apr 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thyroid thermal ablation
Other illness
- 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)
- Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
Age
- \<18 years old or \>89 years old
Other
- Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tulane University School of Medicine Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Sarasota Memorial Health Care System Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.