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Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

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ClinicalTrials.gov Identifier: NCT01024296
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
SurgSolutions, LLC
Information provided by (Responsible Party):
Thomas Krummel, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hernia, Abdominal
Intervention: Device: Port Close

  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
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Reporting Groups
  Description
Gastric Bypass Surgery Patients Port Close: Device for applying loop suture to close surgical site

Participant Flow:   Overall Study
    Gastric Bypass Surgery Patients
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics

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
Gastric Bypass Surgery Patients Port Close: Device for applying loop suture to close surgical site

Baseline Measures
   Gastric Bypass Surgery Patients 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 


  Outcome Measures

1.  Primary:   Count of Participants With Successful Port Site Closure Using Port Close Device   [ Time Frame: Day 1, at the end of surgery ]

2.  Primary:   Time of Port Site Closure   [ Time Frame: Day 1, from insertion to removal of Port Close device during surgery ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bilal M Shafi, MD
Organization: Stanford University
phone: (215) 738-0400
e-mail: bmshafi@stanford.edu



Responsible Party: Thomas Krummel, Stanford University
ClinicalTrials.gov Identifier: NCT01024296     History of Changes
Other Study ID Numbers: SU-11062009-4361
IRB Protocol #8864 ( Other Identifier: Stanford University )
First Submitted: November 13, 2009
First Posted: December 2, 2009
Results First Submitted: September 15, 2017
Results First Posted: October 12, 2017
Last Update Posted: October 12, 2017