- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740480
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
August 20, 2009 updated by: ENTrigue Surgical, Inc.
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital
-
-
Texas
-
Bryan, Texas, United States, 77802
- Park Hudson Surgery Center
-
San Antonio, Texas, United States, 78258
- Physician's Ambulatory Surgery Center IV
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients (ages 18-65) with clinically significant nasal septum deviation.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Surgical
Adult population (ages 18-65) with clinically significant nasal septum deviation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coaptation (Tissue Approximation)
Time Frame: One week post surgery
|
Complete tissue approximation at one week.
|
One week post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue Reaction to Implant
Time Frame: One week post surgery
|
None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.
|
One week post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gabriele G Niederauer, Ph.D., ENTrigue Surgical, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
August 21, 2008
First Submitted That Met QC Criteria
August 22, 2008
First Posted (Estimate)
August 25, 2008
Study Record Updates
Last Update Posted (Estimate)
August 25, 2009
Last Update Submitted That Met QC Criteria
August 20, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- CSA 2008-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasal Septum
-
University Hospital, BordeauxCompleted
-
Recep Tayyip Erdogan University Training and Research...Unknown
-
ENTrigue Surgical, Inc.Completed
-
Ankara UniversityCompletedNasal Septum DeviationTurkey
-
Peking University Third HospitalCompleted
-
Hospital de Clinicas de Porto AlegreCompletedDeviated Nasal Septum | Nasal Septal Defect | Nasal Septum, IrregularBrazil
-
University of Southern CaliforniaUnknownDeviated Nasal Septum | Nasal FractureUnited States
-
Chinese Academy of SciencesThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical...UnknownChronic Nasal Septum PerforationChina
-
Diskapi Teaching and Research HospitalCompletedNasal Septum DeviationTurkey
-
Diskapi Teaching and Research HospitalUnknown