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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
  Purpose

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 Intervention
Deviated Nasal Septum
 Device: ENTact™ Septal Stapler

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by ENTrigue Surgical, Inc.:

Primary Outcome Measures:
  • Clinical performance of aged ENTact™ Septal Staples [ Time Frame: One week post op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957502

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

No publications provided

Responsible Party: ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00957502     History of Changes
Other Study ID Numbers: CSA2009-03
Study First Received: August 10, 2009
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nose Deformities, Acquired
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013