Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506149
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Prospective Evaluation of Microwave Ablation MWA in the Treatment of Relapsed Graves Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Evaluation of Microwave Ablation MWA in the Treatment of Relapsed Graves Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Graves disease is the most common cause of hyperthyroidism with conventional treatment options being anti-thyroid drugs ATD radioiodine RAI and surgery For ATD it has been the first-line treatment over decades Despite its ability to induce remission minor side effects such as skin rash gastrointestinal disturbance and arthralgia occur in around 5 of patients while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60 which these patients would require more definitive treatment options with RAI or thyroidectomy However RAI is not preferable in patients with Graves ophthalmopathy as it could further worsen eye symptoms RAI may also cause hypothyroidism in a substantial proportion of patients with a subsequent need for lifelong thyroxine replacement As for thyroidectomy it carries an overall 2-10 risk of complications including bleeding transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism Due to the drawbacks of the various conventional treatment options there has been increasing interest in the development of minimally invasive treatment alternatives in recent years With the evolution of thermal ablative strategies high-intensity focused ultrasound HIFU and radiofrequency ablation RFA have been reported as feasible treatment options for relapsed Graves disease There has also been increasing reports in the use of microwave ablation MWA in the treatment of benign thyroid nodules MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound USG guidance The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect As compared to RFA MWA is not affected by heat sink effect and may require a shorter treatment time Similar to other thermal ablative approaches MWA has the merits of avoiding surgical scar organ preservation as well as being an ambulatory procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None