Status:
UNKNOWN
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Lead Sponsor:
University Health Network, Toronto
Conditions:
Thyroid Diseases
Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will unde...
Detailed Description
Type of Study This is a single center, prospective case series Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we ...
Eligibility Criteria
Inclusion
- \- Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma.
- Total thyroid size is 7-8 cm (no more than 10 cm)
- Their age is ≥18 years and ≤80 years
- Able to give written consent
Exclusion
- \- History of neck surgery or neck radiotherapy
- Recurrent thyroid disease
- Lymph node metastases
- Presence of intraoral infections
- Presence of extrathyroidal or substernal extensions
- Smoking
- Morbid obesity
- Contra-indication to general anesthesia with nasotracheal intubation
- Previous mediastinal surgery
- Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle)
- Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04842942
Start Date
December 1 2019
End Date
July 1 2022
Last Update
April 13 2021
Active Locations (1)
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1
Univeristy Health Network
Toronto, Ontario, Canada, M5G2C4