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Not Yet RecruitingNCT07047859

Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Tongji University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2025-07-15
Primary completion
2029-05-31
Completion
2029-05-31
First posted
2025-07-02
Last updated
2025-07-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07047859. Inclusion in this directory is not an endorsement.