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Trial record 1 of 1 for:    neomend
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NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394978
First Posted: July 15, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lung Cancer
Lung Tumor
Interventions: Other: Control
Device: ProGEL Pleural Air Leak Sealant

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control

No treatment.

Control: Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant

Standard surgical technique plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).


Participant Flow:   Overall Study
    Control   ProGEL Pleural Air Leak Sealant
STARTED   168   276 
COMPLETED   147   245 
NOT COMPLETED   21   31 
Withdrawal by Subject                2                4 
Lost to Follow-up                13                20 
Death                6                7 



  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.
No text entered.

Reporting Groups
  Description
Control

No treatment.

Control: Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant

Standard surgical technique plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Total Total of all reporting groups

Baseline Measures
   Control   ProGEL Pleural Air Leak Sealant   Total 
Overall Participants Analyzed 
[Units: Participants]
 168   276   444 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      69  41.1%      122  44.2%      191  43.0% 
>=65 years      99  58.9%      154  55.8%      253  57.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (11.46)   65.6  (10.52)   65.6  (10.87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      81  48.2%      136  49.3%      217  48.9% 
Male      87  51.8%      140  50.7%      227  51.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White      156  92.9%      258  93.5%      414  93.2% 
Black      8   4.8%      15   5.4%      23   5.2% 
Asian      1   0.6%      1   0.4%      2   0.5% 
Hispanic      2   1.2%      1   0.4%      3   0.7% 
Other      1   0.6%      1   0.4%      2   0.5% 
Region of Enrollment 
[Units: Participants]
     
United States   168   276   444 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 169.3  (9.93)   170.1  (9.63)   169.8  (9.74) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 79.9  (19.75)   80.5  (20.54)   80.3  (20.22) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.8  (6.16)   27.7  (6.10)   27.7  (6.11) 
BMI Category at Baseline 
[Units: Participants]
Count of Participants
     
<30 kg/sq. meters      117  69.6%      197  71.4%      314  70.7% 
>= 30 kg/sq. meters      51  30.4%      79  28.6%      130  29.3% 


  Outcome Measures

1.  Primary:   Safety Endpoints   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dawn Heimer, PhD
Organization: Davol, Inc.
phone: +1-401-825-8681
e-mail: Dawn.Heimer@CRBard.com



Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01394978     History of Changes
Other Study ID Numbers: NEO09-100
First Submitted: July 13, 2011
First Posted: July 15, 2011
Results First Submitted: April 17, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017