ENTact™ Septal Stapler Shelf Life Extension

Deviated Nasal Septum Clinical Trial

— SSLE  

Official title:

A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957502
• Other study ID #: CSA2009-03
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: August 21, 2012
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2012
• Source: ENTrigue Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deviated Nasal Septum

Intervention

Device:
• ENTact™ Septal Stapler
1 year aged septal staples
• ENTact™ Septal Stapler
18 Month Aged Staples

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ENTrigue Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of aged ENTact™ Septal Staples		One week post op	Yes
Secondary	Clinical evaluation of gross tissue appearance at implantation site(s)		One week post op	Yes
Secondary	ENTact™ Septal Staple functionality based on maintained coaptation		One week post op	Yes