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

This study has been completed.

Sponsor:

Information provided by:

ENTrigue Surgical, Inc.

ClinicalTrials.gov Identifier:

NCT00740480

First received: August 21, 2008

Last updated: August 20, 2009

Last verified: August 2009

History of Changes

Results First Received: July 15, 2009

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Condition:	Nasal Septum

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Septal Stapler Group	Adult population (ages 18-65) with clinically significant nasal septum deviation.

Participant Flow: Overall Study

	Septal Stapler Group
STARTED	25
COMPLETED	23
NOT COMPLETED	2
Adverse Event	1
Physician Decision	1

Baseline Characteristics

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Reporting Groups

	Description
Septal Stapler Group	Adult population (ages 18-65) with clinically significant nasal septum deviation.

Baseline Measures

	Septal Stapler Group
Number of Participants [units: participants]	25
Age [units: participants]
<=18 years	0
Between 18 and 65 years	25
>=65 years	0
Age [units: years] Mean ± Standard Deviation	39.9 ± 13.7
Gender [units: participants]
Female	13
Male	12
Region of Enrollment [units: participants]
United States	25

Outcome Measures

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1. Primary:

Coaptation (Tissue Approximation) [ Time Frame: One week post surgery ]

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2. Secondary:

Tissue Reaction to Implant [ Time Frame: One week post surgery ]

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Measure Type	Secondary
Measure Title	Tissue Reaction to Implant
Measure Description	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.
Time Frame	One week post surgery
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

Reporting Groups

	Description
Septal Stapler Group	Adult population (ages 18-65) with clinically significant nasal septum deviation.

Measured Values

	Septal Stapler Group
Number of Participants Analyzed [units: participants]	25
Tissue Reaction to Implant [units: participants]
No reaction	18
Mild reaction	5
Moderate reaction	0
Severe reaction	0
Cannot assess	2

No statistical analysis provided for Tissue Reaction to Implant

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gabriele Niederauer, PhD
Organization: ENTrigue Surgical, Inc.
phone: 210-298-6398 ext 6336
e-mail: gabi.niederauer@entriguesurgical.com

No publications provided

Responsible Party:	Gabriele Niederauer, Ph.D./Vice President, Research and Development, ENTrigue Surgical, Inc.
ClinicalTrials.gov Identifier:	NCT00740480 History of Changes
Other Study ID Numbers:	CSA 2008-01
Study First Received:	August 21, 2008
Results First Received:	July 15, 2009
Last Updated:	August 20, 2009
Health Authority:	United States: Institutional Review Board

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