NCT00922155

Brief Summary

The purpose of this study is to examine the usefulness of a balloon covered sheath as a guide sheath in endobronchial ultrasound guided transbronchial biopsy and bronchial brushing cytology for diagnosis of peripheral lung lesions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

June 17, 2009

Status Verified

March 1, 2007

Enrollment Period

11 months

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

Pulmonary NeoplasmsSolitary Pulmonary Nodules

Keywords

endobronchial ultrasoundguide sheathperipheral pulmonary lesions

Outcome Measures

Primary Outcomes (1)

  • the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)

    1 year

Secondary Outcomes (1)

  • complications, including bleeding, pneumothorax, respiratory failure,

    1 year

Study Arms (2)

EBUS

NO INTERVENTION

After the PPLs been localized by endobronchial ultrasound(EBUS), patients in the EBUS group received transbronchial biopsy and bronchial washing at the bronchus located by EBUS.

EBUS-GS

ACTIVE COMPARATOR

After PPLs been localized by EBUS, the EBUS and guide sheath were then inserted to localize the lesion again. Transbronchial biopsy and brushing were done through the guide sheath after the probe been removed.

Device: guide sheath

Interventions

guide sheathDEVICE

The guide sheath (GS) was originally the balloon covered sheath (MAJ-643R, external diameter 2.6mm) of the EBUS probe. The two ends of the balloon covered sheath were cut and trimmed. The EBUS probe was covered with guide sheath and then inserted through the working channel to the targeted bronchus.

EBUS-GS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with peripheral pulmonary lesions who are going to receive bronchoscopy

You may not qualify if:

  • endobronchial abnormalities
  • associated lung parenchyma changes, ex. lung collapse or atelectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department or Chest Medicine, Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

MeSH Terms

Conditions

Lung NeoplasmsSolitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2009

Last Updated

June 17, 2009

Record last verified: 2007-03

Locations

TW(1)