MedTrace Logo

ENTact™ Septal Stapler Shelf Life Extension

NCT00957502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-08-23

No results posted yet for this study

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.

Conditions

  • Deviated Nasal Septum

Interventions

DEVICE

ENTact™ Septal Stapler

1 year aged septal staples

DEVICE

ENTact™ Septal Stapler

18 Month Aged Staples

Sponsors & Collaborators

  • ENTrigue Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas A Tami, MD · Good Samaritan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957502 on ClinicalTrials.gov