ENTact™ Septal Stapler Shelf Life Extension

Not Applicable

Completed

• Conditions: Deviated Nasal Septum
• Interventions: Device: ENTact™ Septal Stapler

• Registration Number: NCT00957502
• Lead Sponsor: ENTrigue Surgical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One year aged staples	ENTact™ Septal Stapler	Subjects implanted with sterile staples aged to approximately one year.
18 month aged staples	ENTact™ Septal Stapler	Subjects implanted with sterile staples aged to approximately 18 months.

Primary Outcome Measures

Name	Time	Method
Clinical performance of aged ENTact™ Septal Staples	One week post op

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States