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ENTact™ Septal Stapler Shelf Life Extension (SSLE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957502
First Posted: August 12, 2009
Last Update Posted: August 23, 2012
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):
ENTrigue Surgical, Inc.
August 10, 2009
August 12, 2009
August 23, 2012
July 2009
February 2010   (Final data collection date for primary outcome measure)
Clinical performance of aged ENTact™ Septal Staples [ Time Frame: One week post op ]
Same as current
Complete list of historical versions of study NCT00957502 on ClinicalTrials.gov Archive Site
  • Clinical evaluation of gross tissue appearance at implantation site(s) [ Time Frame: One week post op ]
  • ENTact™ Septal Staple functionality based on maintained coaptation [ Time Frame: One week post op ]
Same as current
Not Provided
Not Provided
 
ENTact™ Septal Stapler Shelf Life Extension
A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Deviated Nasal Septum
  • Device: ENTact™ Septal Stapler
    1 year aged septal staples
  • Device: ENTact™ Septal Stapler
    18 Month Aged Staples
  • Experimental: One year aged staples
    Subjects implanted with sterile staples aged to approximately one year.
    Intervention: Device: ENTact™ Septal Stapler
  • Experimental: 18 month aged staples
    Subjects implanted with sterile staples aged to approximately 18 months.
    Intervention: Device: ENTact™ Septal Stapler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
  • Patient is able to provide a signed informed consent form.
  • Patient will agree to comply with all study related procedures.
  • Subject is not pregnant at this time by confirmation of one of the following:

    • subject is male,
    • subject not of child bearing age,
    • subject is surgically sterile,
    • subject is not pregnant per negative hCG test.
  • Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

  • Patients who have had previous septoplasty
  • Patients with uncontrolled diabetes
  • Presence of infection at the study site
  • Subject is a:

    • smoker,
    • severe drug abuser,
    • severe alcohol abuser.
  • Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00957502
CSA2009-03
No
Not Provided
Not Provided
ENTrigue Surgical, Inc.
ENTrigue Surgical, Inc.
Not Provided
Principal Investigator: Thomas A Tami, MD Good Samaritan Hospital
ENTrigue Surgical, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP