Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
This study has been completed.
Information provided by:
ENTrigue Surgical, Inc.
First received: August 21, 2008
Last updated: August 20, 2009
Last verified: August 2009
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties
Primary Outcome Measures:
- Coaptation (Tissue Approximation) [ Time Frame: One week post surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tissue Reaction to Implant [ Time Frame: One week post surgery ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2009 (Final data collection date for primary outcome measure)
Adult population (ages 18-65) with clinically significant nasal septum deviation.
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
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult patients (ages 18-65) with clinically significant nasal septum deviation.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740480
|Good Samaritan Hospital
|Cincinnati, Ohio, United States, 45220 |
|Park Hudson Surgery Center
|Bryan, Texas, United States, 77802 |
|Physician's Ambulatory Surgery Center IV
|San Antonio, Texas, United States, 78258 |
ENTrigue Surgical, Inc.
||Gabriele G Niederauer, Ph.D.
||ENTrigue Surgical, Inc.
No publications provided
||Gabriele Niederauer, Ph.D./Vice President, Research and Development, ENTrigue Surgical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2008
|Results First Received:
||July 15, 2009
||August 20, 2009
||United States: Institutional Review Board
Keywords provided by ENTrigue Surgical, Inc.:
ClinicalTrials.gov processed this record on April 16, 2014