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

NCT ID: NCT03325907

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-armed feasibility trial
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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template-guided biopsy

Participants receive transthoracic lung biopsy guided by navigational template.

Group Type EXPERIMENTAL

navigational template

Intervention Type DEVICE

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

Interventions

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navigational template

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Chang Chen

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Chen, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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E H, Chen J, Sun W, Zhang Y, Ren S, Shi J, Wen Y, Su C, Ni J, Zhang L, He Y, Chen B, Casal RF, Kheir F, Ishiwata T, Zhang J, Zhao D, Chen C. Three-dimensionally printed navigational template: a promising guiding approach for lung biopsy. Transl Lung Cancer Res. 2022 Mar;11(3):393-403. doi: 10.21037/tlcr-22-172.

Reference Type DERIVED
PMID: 35399565 (View on PubMed)

Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1.

Reference Type RESULT
PMID: 29017792 (View on PubMed)

Other Identifiers

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K17-155

Identifier Type: -

Identifier Source: org_study_id

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