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Needlescopic-assisted Uniportal vs Uniportal VATS (UNeed)

I

IRB of NTUH Hsin-Chu Branch

Status

Completed

Conditions

Lung Cancer Metastatic
Nodule Solitary Pulmonary
Lung Cancer
Bullous Disease Lung
Mediastinal Tumor

Treatments

Procedure: Thoracoscopic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03439696
106-067-F

Details and patient eligibility

About

The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

Enrollment

110 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion criteria

Thoracoscopic esophagectomy Decortication for empyema

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Needlescopic-assisted
Experimental group
Description:
Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.
Treatment:
Procedure: Thoracoscopic surgery
Uniportal
Active Comparator group
Description:
Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision
Treatment:
Procedure: Thoracoscopic surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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