NCT01166516

Brief Summary

Study to collect post-market safety data for HUD IBV Valve System, a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

5.9 years

First QC Date

July 13, 2010

Last Update Submit

April 16, 2018

Conditions

Prolonged Air Leak

Keywords

Prolonged air leaklobectomysegmentectomylung volume reduction surgery (LVRS)

Outcome Measures

Primary Outcomes (1)

  • Safety

    The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.

    Day 0 to 6 weeks

Secondary Outcomes (1)

  • Probable Benefit

    Day 0 to 6 weeks

Study Arms (1)

Treatment with HUD IBV Valve System

OTHER

Treatment with HUD IBV Valve System in Post-Approval Study

Device: Treatment with HUD IBV Valve System

Interventions

Treatment with HUD IBV Valve SystemDEVICE

Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.

Also known as: IBV Valve System
Treatment with HUD IBV Valve System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak is 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise

You may not qualify if:

  • Air leak only on force exhalation or cough
  • Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis
  • Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient
  • Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
  • Subject has co-morbidities or factors that will prevent follow-up during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

University of Chicago

Chicago, Illinois, 60561, United States

Location

SIU School of Medicine

Springfield, Illinois, 62794, United States

Location

Olathe Medical Center

Olathe, Kansas, 66061, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Michael DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington

Seattle, Washington, 98115, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Douglas E. Wood, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 21, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2016

Study Completion

July 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(13)