Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 7:39 PM
Study NCT ID:
NCT06607133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules
Sponsor:
Ming-an Yu
Organization:
Study Overview
Official Title:
Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
Detailed Description:
Large benign thyroid nodules （BTNs）usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: