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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04690790
Other study ID # EMRP56109N
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 23, 2021
Est. completion date December 31, 2021

Study information

Verified date January 2021
Source E-DA Hospital
Contact Ming-Wei Kao, M.D., M.S.
Phone +886-7-6150011
Email ed107576@edah.org.tw
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.


Description:

Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Age ? 20 years - Lung nodule size ?2cm on the pre-operative computed tomography (CT) - Nodulectomy is performed under thoracoscopy Exclusion Criteria: - Age < 20 years - Lung nodule size > 2cm on CT or in the final pathology report - Open surgery for nodulectomy

Study Design


Intervention

Procedure:
Thoracoscopy
Patients who are indicated for thoracoscopic nodulectomy.

Locations

Country Name City State
Taiwan E-DA Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nodule detection Whether the nodule could be detected by conventional visualization or palpation During surgery
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