Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT07047859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
Sponsor:
Tongji University
Organization:
Study Overview
Official Title:
Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective, single-center observational study evaluates the clinical utility of intraoperative sympathetic nerve width measurement during thoracoscopic sympathectomy (ETS) for palmar/craniofacial hyperhidrosis (PH/CH) and facial blushing (FF). The study aims to correlate nerve width-measured using a novel Rapid Intraoperative Sympathetic Nerve Width System (RMSNW-OS) (±0.2mm precision)-with surgical outcomes, compensatory sweating rates, patient satisfaction, and 12-month efficacy.
Approximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar/forehead temperature), hemodynamic (HR/BP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).
Statistical analysis will determine if nerve width predicts treatment response. Innovations include RMSNW-OS standardization and a multidimensional assessment framework to optimize ETS precision and patient quality of life.
Approximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar/forehead temperature), hemodynamic (HR/BP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).
Statistical analysis will determine if nerve width predicts treatment response. Innovations include RMSNW-OS standardization and a multidimensional assessment framework to optimize ETS precision and patient quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: