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
  Purpose

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.


Condition
Nasal Septum

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties

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

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 ]

Enrollment: 25
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical
Adult population (ages 18-65) with clinically significant nasal septum deviation.

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740480

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
United States, Texas
Park Hudson Surgery Center
Bryan, Texas, United States, 77802
Physician's Ambulatory Surgery Center IV
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
ENTrigue Surgical, Inc.
Investigators
Study Director: Gabriele G Niederauer, Ph.D. ENTrigue Surgical, Inc.
  More Information

No publications provided

Responsible Party: Gabriele Niederauer, Ph.D./Vice President, Research and Development, ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00740480     History of Changes
Other Study ID Numbers: CSA 2008-01
Study First Received: August 21, 2008
Results First Received: July 15, 2009
Last Updated: August 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by ENTrigue Surgical, Inc.:
Evaluation
ENTact™
Septal
Staple
System
tissue
approximation
during
septoplasties

ClinicalTrials.gov processed this record on August 28, 2014