NCT01872312

Brief Summary

This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 25, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2014

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

April 10, 2013

Last Update Submit

June 24, 2022

Conditions

Management of BPF (Bronchopleural Fistulae)

Keywords

BPF(Bronchopleural fistulae)

Outcome Measures

Primary Outcomes (2)

  • resolution of BPF (Bronchopleural Fistulae)

    expected resolution of BPF (Bronchopleural Fistulae) in three weeks

    6 weeks

  • resolutin of BPF

    anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks

    6 weeks

Study Arms (1)

treatment

OTHER

Loading IBV® Valve System

Device: treatment with valves (The Spiration® IBV Valve System)

Interventions

treatment with valves (The Spiration® IBV Valve System)DEVICE

treat BPF

Also known as: spiration valve, IBV Valve System
treatment

Eligibility Criteria

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

You may qualify if:

  • Unresolved BPF
  • Not candidate for surgical repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSUMC

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • shaheen Islam, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

April 10, 2013

First Posted

June 7, 2013

Study Start

March 25, 2012

Primary Completion

February 14, 2014

Study Completion

February 14, 2014

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

US(1)