PleuraSeal Pivotal Study (US) | NCT00748124

Studies
PleuraSeal Pivotal Study (US)

NCT00748124

Sponsor

Integra LifeSciences Corporation

Status

Terminated

Last Update Posted

Sep 11, 2014Estimated

Enrollment

230Actual

Phase

Phase 3

Conditions

Open Thoracotomy

Interventions

PleuraSeal Sealant System
Standard Tissue Closure Techniques

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis results were not supportive of primary endpoint

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 4, 2008

First Submission Date that Met QC Criteria

Sep 5, 2008

First Posted Date

Sep 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 22, 2013

Certification/Extension First Submitted that Passed QC Review

Feb 22, 2013

Certification/Extension First Posted Date

Feb 28, 2013Estimated

Last Update Submitted Date

Sep 4, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PleuraSeal Sealant Device	Experimental		Device: PleuraSeal Sealant System Procedure: Standard Tissue Closure Techniques
Control	Other		Procedure: Standard Tissue Closure Techniques

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PleuraSeal Sealant System	Device	Lung Sealant Device + standard tissue closing techniques (sutures/staples)	PleuraSeal Sealant Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.		75 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Confluent Surgical		Bedford	Massachusetts	01730	United States