ENTact™ Septal Stapler Shelf Life Extension (SSLE)

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. Identifier: NCT00957502
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
ENTrigue Surgical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deviated Nasal Septum Device: ENTact™ Septal Stapler Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: One year aged staples
Subjects implanted with sterile staples aged to approximately one year.
Device: ENTact™ Septal Stapler
1 year aged septal staples

Experimental: 18 month aged staples
Subjects implanted with sterile staples aged to approximately 18 months.
Device: ENTact™ Septal Stapler
18 Month Aged Staples

Primary Outcome Measures :
  1. Clinical performance of aged ENTact™ Septal Staples [ Time Frame: One week post op ]

Secondary Outcome Measures :
  1. Clinical evaluation of gross tissue appearance at implantation site(s) [ Time Frame: One week post op ]
  2. ENTact™ Septal Staple functionality based on maintained coaptation [ Time Frame: One week post op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957502

United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
ENTrigue Surgical, Inc.
Principal Investigator: Thomas A Tami, MD Good Samaritan Hospital

Responsible Party: ENTrigue Surgical, Inc. Identifier: NCT00957502     History of Changes
Other Study ID Numbers: CSA2009-03
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012