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Completed

NCT Number: NCT00740480

Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty

The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.

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Key information

Conditions

Nasal Septum

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Good Samaritan Hospital, Cincinnati, Ohio, United States

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About this study

The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate:

  • surgical performance of the ENTact Septal Staple System
  • one week post op clinical evaluation of gross tissue appearance at implantation site(s)
  • ENTact™ Septal Staple functionality based on maintained coaptation

Who can participate

Healthy volunteers accepted: Yes

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
  • Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
  • Patient does not plan on becoming pregnant and is not breast feeding during the course of the study

Exclusion criteria

  • Patients who do not meet the inclusion criteria
  • Patients who have had previous septoplasty
  • Patients with uncontrolled diabetes
  • Presence of infection at the site
  • Smokers and severe drug and alcohol abusers
  • Patients with autoimmune disease deemed clinically significant by Principal Investigator

Treatment and study plan

Primary outcomes

  1. Coaptation (Tissue Approximation)

    Time frame: One week post surgery

    Complete tissue approximation at one week.

Secondary outcomes

  1. Tissue Reaction to Implant

    Time frame: One week post surgery

    None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.

Sponsors and collaborators

Lead sponsor

ENTrigue Surgical, Inc.

Industry

Registry information

Official study title

A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2008
Registry last updated
Aug 25, 2009

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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