NCT00957502CompletedNot Applicable
A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ENTrigue Surgical, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Clinical performance of aged ENTact™ Septal Staples
Study Overview
Brief Summary
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Subject is not pregnant at this time by confirmation of one of the following:
- •subject is male,
- •subject not of child bearing age,
- •subject is surgically sterile,
- •subject is not pregnant per negative hCG test.
- •Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
Exclusion Criteria
- •Patients who have had previous septoplasty
- •Patients with uncontrolled diabetes
- •Presence of infection at the study site
- •Subject is a:
- •severe drug abuser,
- •severe alcohol abuser.
- •Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Arms & Interventions
One year aged staples
Experimental
Subjects implanted with sterile staples aged to approximately one year.
Intervention: ENTact™ Septal Stapler (Device)
18 month aged staples
Experimental
Subjects implanted with sterile staples aged to approximately 18 months.
Intervention: ENTact™ Septal Stapler (Device)
Outcomes
Primary Outcomes
Clinical performance of aged ENTact™ Septal Staples
Time Frame: One week post op
Secondary Outcomes
- Clinical evaluation of gross tissue appearance at implantation site(s)(One week post op)
- ENTact™ Septal Staple functionality based on maintained coaptation(One week post op)
Investigators
Study Sites (1)
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