Trial Outcomes & Findings for Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty (NCT NCT00740480)

Results Overview

Complete tissue approximation at one week.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

One week post surgery

Results posted on

2009-08-25

Participant Flow

Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.

Participant milestones

Participant milestones
Measure	Septal Stapler Group Adult population (ages 18-65) with clinically significant nasal septum deviation.
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Septal Stapler Group Adult population (ages 18-65) with clinically significant nasal septum deviation.
Overall Study Adverse Event	1
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Septal Stapler Group n=25 Participants Adult population (ages 18-65) with clinically significant nasal septum deviation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39.9 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: One week post surgery

Population: ITT

Complete tissue approximation at one week.

Outcome measures

Outcome measures
Measure	Septal Stapler Group n=25 Participants Adult population (ages 18-65) with clinically significant nasal septum deviation.
Coaptation (Tissue Approximation)	23 participants

SECONDARY outcome

Timeframe: One week post surgery

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Septal Stapler Group n=25 Participants Adult population (ages 18-65) with clinically significant nasal septum deviation.
Tissue Reaction to Implant Mild reaction	5 participants
Tissue Reaction to Implant Moderate reaction	0 participants
Tissue Reaction to Implant No reaction	18 participants
Tissue Reaction to Implant Severe reaction	0 participants
Tissue Reaction to Implant Cannot assess	2 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gabriele Niederauer, PhD

ENTrigue Surgical, Inc.

Phone: 210-298-6398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place