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

Sarasota Memorial Health Care System

Status: Invitation-only

Conditions: Hyperthyroidism; Multinodular Goiter; Thyroid Disease; Hyperthyroidism; Goiter; Toxic Multinodular Goiter; Thyroid Nodules

Treatments: Other: Data Collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06868459

24-ENT-97

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

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.

Treatment:

Other: Data Collection