Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-19 @ 10:21 AM
Study NCT ID:
NCT03158961
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong.
The following are the procedure of the study:
1. Recruit patients from the clinic.
2. Patients will receive treatment within 3 months
3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.
4. Patients will be monitoring by the same team after the study.
The following are the procedure of the study:
1. Recruit patients from the clinic.
2. Patients will receive treatment within 3 months
3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.
4. Patients will be monitoring by the same team after the study.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: