Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2009-07-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One year aged staples
Subjects implanted with sterile staples aged to approximately one year.
ENTact™ Septal Stapler
1 year aged septal staples
18 month aged staples
Subjects implanted with sterile staples aged to approximately 18 months.
ENTact™ Septal Stapler
18 Month Aged Staples
Interventions
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ENTact™ Septal Stapler
1 year aged septal staples
ENTact™ Septal Stapler
18 Month Aged Staples
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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ENTrigue Surgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas A Tami, MD
Role: PRINCIPAL_INVESTIGATOR
Good Samaritan Hospital
Locations
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Good Samaritan Hospital
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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CSA2009-03
Identifier Type: -
Identifier Source: org_study_id