Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Adult population (ages 18-65) with clinically significant nasal septum deviation. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Coaptation (Tissue Approximation) | Complete tissue approximation at one week. | One week post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Reaction to Implant | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult patients (ages 18-65) with clinically significant nasal septum deviation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabriele G Niederauer, Ph.D. | ENTrigue Surgical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States | ||
| Park Hudson Surgery Center |
Not provided
Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Septal Stapler Group | Adult population (ages 18-65) with clinically significant nasal septum deviation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Septal Stapler Group | Adult population (ages 18-65) with clinically significant nasal septum deviation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coaptation (Tissue Approximation) | Complete tissue approximation at one week. | ITT | Posted | Number | participants | One week post surgery |
|
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriele Niederauer, PhD | ENTrigue Surgical, Inc. | 210-298-6398 | 6336 | gabi.niederauer@entriguesurgical.com |
Not provided
Not provided
Not provided
Not provided
| One week post surgery |
| Bryan |
| Texas |
| 77802 |
| United States |
| Physician's Ambulatory Surgery Center IV | San Antonio | Texas | 78258 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Tissue Reaction to Implant | 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. | ITT | Posted | Number | participants | One week post surgery |
|
|
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Severe reaction |
|
| Cannot assess |
|