PleuraSeal Post Market Study (Europe)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Conditions:	Lung Disease; Pulmonary Lobectomy
Interventions:	Procedure: Standard Tissue Closure Techniques; Device: PleuraSeal Lung Sealant System

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 28, 2008 and October 21, 2008, a total of 161 subjects were consented and screened for potential study participation at 8 institutions (hospitals). Of these subjects, 121 were randomized.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were evaluated for pre-operative and intra-operative eligibility criteria. Randomization occurred intra-operatively.

Reporting Groups

	Description
PleuraSeal	PleuraSeal Lung Sealant System
Standard of Care	Standard tissue closure techniques (control) - sutures or staples only

Participant Flow:   Overall Study

	PleuraSeal	Standard of Care
STARTED	62	59
COMPLETED	61 [1]	59 [2]
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

[1]	One subject withdrew consent prior to study completion. No reason given.
[2]	All control subjects completed the study.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
PleuraSeal	PleuraSeal Lung Sealant System
Standard of Care	Standard tissue closure techniques (control) - sutures or staples only
Total	Total of all reporting groups

Baseline Measures

	PleuraSeal	Standard of Care	Total
Overall Participants Analyzed; [Units: Participants]	62	59	121
Age; [Units: Years]; Mean (Standard Deviation)	61.5 (9.1)	62.8 (10.8)	62.1 (9.9)
Gender; [Units: Participants]
Female	26	22	48
Male	36	37	73
Race/Ethnicity, Customized; [Units: Participants]
Caucasian	61	55	116
African	0	1	1
Asian	0	1	1
Hispanic	0	1	1
Other	1	1	2
Region of Enrollment; [Units: Participants]
Netherlands	9	6	15
Belgium	14	14	28
United Kingdom	6	4	10
Austria	32	30	62
Switzerland	1	5	6
Nicotine Use; [Units: Participants]
History	31	34	65
Current	22	17	39
Never	9	8	17
Body Mass Index; [Units: Kg/m^2]; Mean (Standard Deviation)	25.86 (4.73)	26.35 (4.55)	26.10 (4.63)
Height; [Units: Cm]; Mean (Standard Deviation)	169.5 (8.8)	169.4 (9.6)	169.4 (9.1)
Weight; [Units: Kg]; Mean (Standard Deviation)	74.46 (15.35)	75.57 (13.96)	75.00 (14.64)

  Outcome Measures

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1. Primary:

Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge. [ Time Frame: 30 days ]

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2. Primary:

Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge [ Time Frame: 30 days ]

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3. Secondary:

Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved. [ Time Frame: Intra-operatively, time of study procedure ]

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4. Secondary:

Time From Skin Closure to Last Observable Air Leak. [ Time Frame: 30 days ]

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5. Secondary:

Duration of Chest Drainage [ Time Frame: 30 days ]

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6. Secondary:

Duration of Hospitalization [ Time Frame: 30 days ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Institution and Investigator agree to submit the draft of any proposed publication to Sponsor at least 30 dyas prior to submission for publication, presentation, or use, and agrees, at the request of the Sponsor, to withhold any such submission for an additional period, not to exceed 90 days to allow Sponsor to file patent applications. The first publication of the results shall be made in conjunction with the presentation of a joint, multi-center publication.

Results Point of Contact:  

Name/Title: Jennifer L. Doyle, Global Director of Clinical Affairs
Organization: Covidien
phone: 781-839-1770
e-mail: jennifer.doyle@covidien.com

Responsible Party:	Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:	NCT00704171 History of Changes
Other Study ID Numbers:	LUN-06-002
First Submitted:	June 23, 2008
First Posted:	June 24, 2008
Results First Submitted:	December 21, 2009
Results First Posted:	March 15, 2010
Last Update Posted:	October 27, 2016