NCT03793387

Brief Summary

Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

January 2, 2019

Last Update Submit

February 26, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Successful localization

    Discrepancy from lesion to marking: less than 1 cm

    2 days

  • Successful resection

    Lesion contained in first resected specimen

    2 days

Secondary Outcomes (3)

  • Localization duration

    1 day

  • Total radiation exposure

    2 days

  • Complication

    14 days

Study Arms (2)

Pre-op

EXPERIMENTAL
Procedure: AF-guided endobronchial marking

Intra-op

ACTIVE COMPARATOR
Device: ENB-guided endobronchial marking

Interventions

AF-guided endobronchial markingPROCEDURE

Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance

Pre-op
ENB-guided endobronchial markingDEVICE

Bronchoscopic dye marking with ENB system

Intra-op

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20\~90 years old C. sign permit

You may not qualify if:

  • A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, 30059, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Shun-Mao Yang, MD

CONTACT

+886-972-654-475mutayang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

July 8, 2019

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

TW(1)