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具有压力逆行的逆行闭塞疗法,并栓塞用于控制甲状腺疾病(保护注册):多中心注册表

2026年9月25日 更新者:Ralph Tufano、Sarasota Memorial Health Care System

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.

研究概览

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic
      • Sarasota、Florida、美国、34239
        • Sarasota Memorial Health Care System
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University School of Medicine
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane University School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 89年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients that may be included in the registry study are those who have undergone PED-TAE using TriNav at the selected study sites. Data will be collected on patients meeting eligibility criteria.

Study subjects will not be informed of their inclusion in this registry dataset, and the results of this research will not be reported to study subjects at the conclusion of the study.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:OTHER

队列和干预

团体/队列
干预/治疗
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.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
ThyPro-39 questionnaire
大体时间: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.

6 months
Procedure related adverse events
大体时间: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.

6 months

次要结果测量

结果测量
措施说明
大体时间
Thyroid volume change
大体时间:6 months

Thyroid volume change based on 3D CT volumetry at 6-months (+/- 60 days) post-treatment

6 months
Change in TSH, T3 and T4
大体时间:6 months

Change in TSH, T3 and T4 levels at 2-weeks (+/- 7 days), 3-(+/- 30 days) and 6-months (+/- 60 days) post-treatment

6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Tamela Fonseca, PhD, RN, CCRC, NE-BC、Sarasota Memorial Health Care System

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2025年3月5日

首先提交符合 QC 标准的

2025年3月5日

首次发布 (实际的)

2025年3月11日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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