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ENTact™ Septal Stapler Shelf Life Extension (SSLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00957502
First received: August 10, 2009
Last updated: August 21, 2012
Last verified: August 2012
History of Changes

August 10, 2009
August 21, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • ENTact™ Septal Staple functionality based on maintained coaptation [ Time Frame: One week post op ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957502
CSA2009-03
No
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