Thyroid DiseasesPhase 1NCT04842942
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
A Phase 1 study testing TOETVA in people with Thyroid Diseases and Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Diseases, Surgery
- What is being tested?
- TOETVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - History of neck surgery or neck radiotherapy
- Recurrent thyroid disease
- Lymph node metastases
- Presence of intraoral infections
- Presence of extrathyroidal or substernal extensions
- Smoking
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Univeristy Health Network
Toronto, Ontario, M5G2C4
Jesse D Pasternak, MD, 4163405195, jesse.pasternak@uhn.ca
About this study
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.
Read the 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 will perform the same study in more patients using the results of this study for a power size calculation.
Study Population Patients (> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.
Study Design 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.
Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario.
Endpoints of the study The main study endpoints consist of
- Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay.
- Quality of Life - EORTC Thyroid specific Health related quality of life
These endpoints will be compared to historical age/indication controls for analysis.
- Conditions
- Thyroid Diseases, Surgery
- Being tested
- TOETVA
- Keywords
- TOETVA, Transoral Endoscopic Thyroidectomy Vestibular Approach
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOETVAProcedure or surgery
Transoral Endoscopic Thyroidectomy Vestibular Approach
| Study group | Role | What they receive |
|---|---|---|
| TOETVA | Experimental | Transoral Endoscopic Thyroidectomy Vestibular Approach Receives: Procedure: TOETVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative recurrent laryngeal nerve palsy
Number of participants with post-operative recurrent laryngeal nerve palsy
Measured: 12 months
Postoperative hypocalcemia
Number of participants with postoperative hypocalcemia
Measured: 12 months
Neck incision
Number of conversions to open
Measured: 1 month
Rate of oral infections
Number of participants with oral infections
Measured: 12 months
Rate of hematoma
Number of participants with hematomas
Measured: 1 month
Rate of seroma
Number of participants with seromas
Measured: 1 month
Rate of neck infection
Number of participants with neck infections
Measured: 12 months
Rate of subcutaneous emphysema
Number of participants with subcutaneous emphysema
Measured: 12 months
Rate of gas-induced embolism
Number of participants with gas-induced embolism
Measured: 12 months
Surgical time
Surgical time in hours
Measured: until surgical discharge, average of 24 hours
Length of stay
Length of stay in days
Measured: until surgical discharge, average of 24 hours
Secondary outcomes (1)
Quality of Life Score
EORTC Thyroid specific Health related quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse D Pasternak, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842942
- Sponsor's protocol ID
- 19-5679
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
- ClinicalTrials.gov ID
- NCT04842942
- Acronym / sponsor ID
- 19-5679
- Conditions
- Thyroid Diseases, Surgery
- Keywords
- TOETVA, Transoral Endoscopic Thyroidectomy Vestibular Approach
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 will perform the same study in more patients using the results of this study for a power size calculation.
Study Population Patients (> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.
Study Design 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.
Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario.
Endpoints of the study The main study endpoints consist of
- Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay.
- Quality of Life - EORTC Thyroid specific Health related quality of life
These endpoints will be compared to historical age/indication controls for analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
| Arm | Type | Receives |
|---|---|---|
| TOETVA | Experimental | Procedure: TOETVATransoral Endoscopic Thyroidectomy Vestibular Approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- - History of neck surgery or neck radiotherapy
- Recurrent thyroid disease
- Lymph node metastases
- Presence of intraoral infections
- Presence of extrathyroidal or substernal extensions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOETVATransoral Endoscopic Thyroidectomy Vestibular Approach | Procedure or surgery | TOETVA |
Primary outcome
Post-operative recurrent laryngeal nerve palsy
Time frame: 12 months
Number of participants with post-operative recurrent laryngeal nerve palsy
Postoperative hypocalcemia
Time frame: 12 months
Number of participants with postoperative hypocalcemia
Neck incision
Time frame: 1 month
Number of conversions to open
Rate of oral infections
Time frame: 12 months
Number of participants with oral infections
Rate of hematoma
Time frame: 1 month
Number of participants with hematomas
Rate of seroma
Time frame: 1 month
Number of participants with seromas
Rate of neck infection
Time frame: 12 months
Number of participants with neck infections
Rate of subcutaneous emphysema
Time frame: 12 months
Number of participants with subcutaneous emphysema
Rate of gas-induced embolism
Time frame: 12 months
Number of participants with gas-induced embolism
Surgical time
Time frame: until surgical discharge, average of 24 hours
Surgical time in hours
Length of stay
Time frame: until surgical discharge, average of 24 hours
Length of stay in days
1 secondary outcome
Quality of Life Score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse D Pasternak, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TOETVA in people with Thyroid Diseases and Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesse D Pasternak, MD (14163405195, jesse.pasternak@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative recurrent laryngeal nerve palsy (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.