SSLE: ENTact™ Septal Stapler Shelf Life Extension

• Sponsor: ENTrigue Surgical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00957502
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deviated Nasal Septum	Device: ENTact™ Septal Stapler; Device: ENTact™ Septal Stapler	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

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
Experimental: 18 month aged staples Subjects implanted with sterile staples aged to approximately 18 months.	Device: ENTact™ Septal Stapler; 18 Month Aged Staples

Outcome Measures

Primary Outcome Measures

1. Clinical performance of aged ENTact™ Septal Staples [One week post op]

Secondary Outcome Measures

1. Clinical evaluation of gross tissue appearance at implantation site(s) [One week post op]

2. ENTact™ Septal Staple functionality based on maintained coaptation [One week post op]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• ENTrigue Surgical, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ENTrigue Surgical, Inc.
• ClinicalTrials.gov Identifier: NCT00957502
• Other Study ID Numbers: CSA2009-03
• First Posted: Aug 12, 2009
• Last Update Posted: Aug 23, 2012
• Last Verified: Aug 1, 2012

Study Results

No Results Posted as of Aug 23, 2012