Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ThyPro-39 questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •<18 years old or >89 years old
- •Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
- •Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
- •Prior thyroid thermal ablation
结局指标
主要结局
ThyPro-39 questionnaire
时间窗: 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
时间窗: 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.
次要结局
- Thyroid volume change(6 months)
- Change in TSH, T3 and T4(6 months)
研究者
Juan C. Camacho, MD
Principal Investigator
Sarasota Memorial Health Care System