New Intraoperative Nerve Monitoring Device
IONM
Evaluation of the Usability and Safety of the Newly Developed Piezoelectric Sensor Intraoperative Nerve Monitoring Device in Thyroid and Parathyroid Surgery: A Pilot Study
2 other identifiers
interventional
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJuly 17, 2025
July 1, 2025
5 months
July 8, 2025
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrent nerve identification
nerve will be identified with new device
introperatively
Study Arms (1)
thyro,d cases
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18-70, diagnosis of benign/malignant thyroid disease, informed consent
You may not qualify if:
- History of previous nerve injury, concomitant neurological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr
Study Record Dates
First Submitted
July 8, 2025
First Posted
July 17, 2025
Study Start
August 1, 2025
Primary Completion
January 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
No need