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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014