ENTact™ Septal Stapler Shelf Life Extension
SSLE
A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedAugust 23, 2012
August 1, 2012
7 months
August 10, 2009
August 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performance of aged ENTact™ Septal Staples
One week post op
Secondary Outcomes (2)
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
Study Arms (2)
One year aged staples
EXPERIMENTALSubjects implanted with sterile staples aged to approximately one year.
18 month aged staples
EXPERIMENTALSubjects implanted with sterile staples aged to approximately 18 months.
Interventions
Eligibility Criteria
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.
- 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.
You may not qualify if:
- Patients who have had previous septoplasty
- Patients with uncontrolled diabetes
- Presence of infection at the study site
- Subject is a:
- smoker,
- severe drug abuser,
- severe alcohol abuser.
- Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A Tami, MD
Good Samaritan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 12, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 23, 2012
Record last verified: 2012-08