New Intraoperative Nerve Monitoring Device | NCT07071571

Studies
New Intraoperative Nerve Monitoring Device

NCT07071571

Sponsor

SB Istanbul Education and Research Hospital

Status

Not yet recruiting

Last Update Posted

Jul 17, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Thryoid Cancer
parathyrıoid Adenoma

Interventions

neuromonitoring

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No any fund	Other Identifier	No any fund

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 16, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erhan Aysan, Prof Dr, SB Istanbul Education and Research HospitalPrincipal Investigator

Lead Sponsor

SB Istanbul Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thyro,d cases	Active Comparator		Device: neuromonitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neuromonitoring	Device	new neuromonitorin device will use	thyro,d cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrent nerve identification	nerve will be identified with new device	introperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70, diagnosis of benign/malignant thyroid disease, informed consent

Exclusion Criteria:

History of previous nerve injury, concomitant neurological disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
erhan aysan, MD Prof	Contact	+902165785000		erhanaysan@hotmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

No need

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided