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

This study has been completed.
Sponsor:
Information provided by:
ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00740480
First received: August 21, 2008
Last updated: August 20, 2009
Last verified: August 2009

August 21, 2008
August 20, 2009
April 2008
February 2009   (final data collection date for primary outcome measure)
Coaptation (Tissue Approximation) [ Time Frame: One week post surgery ] [ Designated as safety issue: No ]
Complete coaptation at one week. [ Time Frame: One week post surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00740480 on ClinicalTrials.gov Archive Site
Tissue Reaction to Implant [ Time Frame: One week post surgery ] [ Designated as safety issue: Yes ]
  • One week visual tissue reaction to implant [ Time Frame: One week post surgery ] [ Designated as safety issue: No ]
  • Intraoperative performance [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties

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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Nasal Septum
Not Provided
Surgical
Adult population (ages 18-65) with clinically significant nasal septum deviation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
February 2009   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria
  • 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740480
CSA 2008-01
No
Gabriele Niederauer, Ph.D./Vice President, Research and Development, ENTrigue Surgical, Inc.
ENTrigue Surgical, Inc.
Not Provided
Study Director: Gabriele G Niederauer, Ph.D. ENTrigue Surgical, Inc.
ENTrigue Surgical, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP