Thryoid CancerIONMNCT07071571
New Intraoperative Nerve Monitoring Device
A study testing neuromonitoring in people with Thryoid Cancer and parathyrıoid Adenoma, run by SB Istanbul Education and Research Hospital.
Trial summary
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thryoid Cancer, parathyrıoid Adenoma
- What is being tested?
- neuromonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70, diagnosis of benign/malignant thyroid disease, informed consent
Who cannot join
- History of previous nerve injury, concomitant neurological disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Usability and Safety of the Newly Developed Piezoelectric Sensor Intraoperative Nerve Monitoring Device in Thyroid and Parathyroid Surgery: A Pilot Study
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries.
Read the detailed description
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries. Such devices are still used in surgical routine, but research has been initiated on this subject due to the higher sensitivity and reliability of this new device.
- Conditions
- Thryoid Cancer, parathyrıoid Adenoma
- Being tested
- neuromonitoring
- Keywords
- neuromonitorization, introperative, recurrent nerve, new device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromonitoringDevice
new neuromonitorin device will use
| Study group | Role | What they receive |
|---|---|---|
| thyro,d cases | Active comparator | Not described Receives: Device: neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent nerve identification
nerve will be identified with new device
Measured: introperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thryoid CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Recurrent nerve monitoring will be performed in patients with thyroid or parathyroid surgery indications.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071571
- Sponsor's protocol ID
- 111.023
- Other IDs
- No any fund
- Acronym
- IONM
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No need
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usability and Safety of the Newly Developed Piezoelectric Sensor Intraoperative Nerve Monitoring Device in Thyroid and Parathyroid Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT07071571
- Acronym / sponsor ID
- IONM / 111.023
- Conditions
- Thryoid Cancer, parathyrıoid Adenoma
- Keywords
- neuromonitorization, introperative, recurrent nerve, new device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (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 study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries.
Detailed description
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries. Such devices are still used in surgical routine, but research has been initiated on this subject due to the higher sensitivity and reliability of this new device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recurrent nerve monitoring will be performed in patients with thyroid or parathyroid surgery indications.
| Arm | Type | Receives |
|---|---|---|
| thyro,d cases | Active comparator | Device: neuromonitoring |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-70, diagnosis of benign/malignant thyroid disease, informed consent
Key exclusion criteria (1 listed)
- History of previous nerve injury, concomitant neurological disorder
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 |
|---|---|---|
| neuromonitoringnew neuromonitorin device will use | Device | thyro,d cases |
Primary outcome
recurrent nerve identification
Time frame: introperatively
nerve will be identified with new device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No. No need
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.
Questions about this trial
What is this clinical trial studying?
A study testing neuromonitoring in people with Thryoid Cancer and parathyrıoid Adenoma, run by SB Istanbul Education and Research Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact erhan aysan, MD Prof (+902165785000, erhanaysan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent nerve identification (time frame: introperatively). 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 17 Jul 2025.