Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.

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Detailed Description

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The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate:

* surgical performance of the ENTact Septal Staple System
* one week post op clinical evaluation of gross tissue appearance at implantation site(s)
* ENTact™ Septal Staple functionality based on maintained coaptation

Conditions

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Nasal Septum

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical

Adult population (ages 18-65) with clinically significant nasal septum deviation.

No interventions assigned to this group

Eligibility Criteria

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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
* Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
* Patient does not plan on becoming pregnant and is not breast feeding during the course of the study

* Patients who have had previous septoplasty
* Patients with uncontrolled diabetes
* Presence of infection at the site
* Smokers and severe drug and alcohol abusers
* Patients with autoimmune disease deemed clinically significant by Principal Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes