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Completed

NCT Number: NCT03325907

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

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

navigational template

Device

The navigational template was created based on computed tomography data using three-dimensional technology.

Primary outcomes

  1. Success rate of needle insertion

    Time frame: 15 minutes

    Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.

Secondary outcomes

  1. procedural length

    Time frame: 1 hour

    The length of procedural time is measured from the time a patient is lying on the examining bed of the CT scanner to the time he/she complete the biopsy procedure and step off the CT table.

  2. radiation dosage

    Time frame: 1 hour

    How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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