ENTact™ Septal Stapler Shelf Life Extension (SSLE)

August 21, 2012 updated by: ENTrigue Surgical, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Device: ENTact™ Septal Stapler
18 Month Aged Staples
EXPERIMENTAL: 18 month aged staples
Subjects implanted with sterile staples aged to approximately 18 months.
Device: ENTact™ Septal Stapler
1 year aged septal staples
Device: ENTact™ Septal Stapler
18 Month Aged Staples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical performance of aged ENTact™ Septal Staples
Time Frame: One week post op
One week post op

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation of gross tissue appearance at implantation site(s)
Time Frame: One week post op
One week post op
ENTact™ Septal Staple functionality based on maintained coaptation
Time Frame: One week post op
One week post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ENTrigue Surgical, Inc.

Investigators

  • Principal Investigator: Thomas A Tami, MD, Good Samaritan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (ESTIMATE)

August 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • CSA2009-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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