Recruiting
Phase 1

Transoral Endoscopic Thyroidectomy

Sponsor:

University Health Network, Toronto

Code:

NCT04842942

Conditions

Thyroid Diseases

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TOETVA

Study Details

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 undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Conditions

Thyroid Diseases

Surgery

Study ID

NCT04842942

Start date

Dec 1, 2019

Status verified date

Apr, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- 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 Criteria:

  • - 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: TOETVA

Transoral Endoscopic Thyroidectomy Vestibular Approach

Interventions

TOETVA

Transoral Endoscopic Thyroidectomy Vestibular Approach

Primary outcome measure

  • Post-operative recurrent laryngeal nerve palsy [ Time Frame: 12 months ]
  • Postoperative hypocalcemia [ Time Frame: 12 months ]
  • Neck incision [ Time Frame: 1 month ]
  • Rate of oral infections [ Time Frame: 12 months ]
  • Rate of hematoma [ Time Frame: 1 month ]
  • Rate of seroma [ Time Frame: 1 month ]
  • Rate of neck infection [ Time Frame: 12 months ]
  • Rate of subcutaneous emphysema [ Time Frame: 12 months ]
  • Rate of gas-induced embolism [ Time Frame: 12 months ]
  • Surgical time [ Time Frame: until surgical discharge, average of 24 hours ]
  • Length of stay [ Time Frame: until surgical discharge, average of 24 hours ]

Central Contacts and Locations

Central contacts

Jesse D Pasternak, MD

14163405195jesse.pasternak@uhn.ca

Locations

Univeristy Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Jesse D Pasternak, MD

4163405195jesse.pasternak@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 13, 2021

Last verified

Apr, 2021

Keywords

  • TOETVA
  • Transoral Endoscopic Thyroidectomy Vestibular Approach

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-04-13.