ENTact™ Septal Stapler Shelf Life Extension
Information source: ENTrigue Surgical, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Septum
Intervention: ENTact™ Septal Stapler (Device); ENTact™ Septal Stapler (Device)
Phase: N/A
Status: Recruiting
Sponsored by: ENTrigue Surgical, Inc. Official(s) and/or principal investigator(s):
Thomas A Tami, MD, Principal Investigator, Affiliation: Good Samaritan Hospital
Overall contact:
Pam Plummer, RN, Phone: 513 862-2877, Email: Pam_Plummer@trihealth.com
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.
Clinical Details
Official title: A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical performance of aged ENTact™ Septal Staples
Secondary outcome: Clinical evaluation of gross tissue
appearance at implantation site(s)ENTact™ Septal Staple functionality based on maintained
coaptation
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
- 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:
- smoker,
- severe drug abuser,
- severe alcohol abuser.
- Patient with autoimmune disease deemed clinically significant by the Principal
Investigator.
Locations and Contacts
Pam Plummer, RN, Phone: 513 862-2877, Email: Pam_Plummer@trihealth.com
Good Samaritan Hospital, Cincinnati, Ohio 45220, United States; Recruiting
Pam Plummer, RN, Phone: 513-862-2877, Email: Pam_Plummer@trihealth.com
Thomas A. Tami, MD, Principal Investigator
Additional Information
Starting date: July 2009
Ending date: November 2009
Last updated: August 11, 2009
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