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Completed

NCT Number: NCT00957502

ENTact™ Septal Stapler Shelf Life Extension

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.

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Key information

Conditions

Deviated Nasal Septum

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ENTact™ Septal Stapler

Device

1 year aged septal staples

Primary outcomes

  1. Clinical performance of aged ENTact™ Septal Staples

    Time frame: One week post op

Secondary outcomes

  1. Clinical evaluation of gross tissue appearance at implantation site(s)

    Time frame: One week post op

  2. ENTact™ Septal Staple functionality based on maintained coaptation

    Time frame: One week post op

Sponsors and collaborators

Lead sponsor

ENTrigue Surgical, Inc.

Industry

Registry information

Official study title

A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life

Acronym: SSLE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 12, 2009
Registry last updated
Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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