Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial

Shanghai Pulmonary Hospital, Shanghai, China

Status: Completed

Conditions: Lung Neoplasms

Treatments: Device: navigational template

Study type: Interventional

Funder types: Other

Identifiers

NCT03325907

K17-155

Details and patient eligibility

About

This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.

Full description

In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

CT confirmed peripheral lung nodule; Nodule size larger than or equal to 3 cm; ECOG Performance Status 0-2 ; Informed consent.

Exclusion criteria

Nodule located in the scapula region wherein biopsy needle is impeded; Nodule within 3 cm above diaphragmatic dome.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

template-guided biopsy

Experimental group

Description:

Participants receive transthoracic lung biopsy guided by navigational template.

Treatment:

Device: navigational template