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
1 other identifier
observational
25
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2008
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 21, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
August 21, 2009
CompletedAugust 25, 2009
August 1, 2009
10 months
August 21, 2008
July 15, 2009
August 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coaptation (Tissue Approximation)
Complete tissue approximation at one week.
One week post surgery
Secondary Outcomes (1)
Tissue Reaction to Implant
One week post surgery
Study Arms (1)
Surgical
Adult population (ages 18-65) with clinically significant nasal septum deviation.
Eligibility Criteria
Adult patients (ages 18-65) with clinically significant nasal septum deviation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Park Hudson Surgery Center
Bryan, Texas, 77802, United States
Physician's Ambulatory Surgery Center IV
San Antonio, Texas, 78258, United States
Results Point of Contact
- Title
- Gabriele Niederauer, PhD
- Organization
- ENTrigue Surgical, Inc.
Study Officials
- STUDY DIRECTOR
Gabriele G Niederauer, Ph.D.
ENTrigue Surgical, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2008
First Posted
August 25, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 25, 2009
Results First Posted
August 21, 2009
Record last verified: 2009-08