ENTact™ Septal Stapler Shelf Life Extension - Full Text View

Sponsor:	ENTrigue Surgical, Inc.
Information provided by:	ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:	NCT00957502

Purpose

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	Intervention
Nasal Septum	Device: ENTact™ Septal Stapler

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life

Further study details as provided by ENTrigue Surgical, Inc.:

Primary Outcome Measures:

Clinical performance of aged ENTact™ Septal Staples [ Time Frame: One week post op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical evaluation of gross tissue appearance at implantation site(s) [ Time Frame: One week post op ] [ Designated as safety issue: Yes ]
ENTact™ Septal Staple functionality based on maintained coaptation [ Time Frame: One week post op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	July 2009
Study Completion Date:	February 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
One year aged staples: Experimental Subjects implanted with sterile staples aged to approximately one year.	Device: ENTact™ Septal Stapler 1 year aged septal staples
18 month aged staples: Experimental Subjects implanted with sterile staples aged to approximately 18 months.	Device: ENTact™ Septal Stapler 18 Month Aged Staples

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957502

Locations

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

Sponsors and Collaborators

ENTrigue Surgical, Inc.

Investigators

Principal Investigator:

Thomas A Tami, MD

Good Samaritan Hospital

More Information

No publications provided

Responsible Party:	ENTrigue Surgical, Inc. ( Gabriele G. Niederauer, PhD )
Study ID Numbers:	CSA2009-03
Study First Received:	August 10, 2009
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00957502 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 08, 2010