Septoplasty
Conditions
Keywords
Septoplasty, ENTACT Septal Stapler
Brief summary
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in Europe (data may be used to support registrations on other countries as well).
Detailed description
The primary objective of this study is to demonstrate clinical success of the ENTACT (Next Generation) resorbable septal staple system by examining the patient's nasal cavity at the 21 day follow-up visit. The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple.
Interventions
DEVICEENTACT Septal Staple system
The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
The patient will be eligible for the study if he or she meets all of the following inclusion criteria at the baseline screening: 1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB); 2. Clinically significant deviation of the nasal septum; 3. Willing and able to make all required study visits; 4. Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)
Exclusion criteria
The patient will be ineligible for the study if he or she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit | 21 days | At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were YES then clinical success was inferred (if any answer was NO then repair failure was inferred). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day: 5, 21, and 42 | At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Complete coaptation of perichondrial flaps on septum wall. |
| Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day: 5, 21, and 42 | At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Absence of significant local tissue reaction at the staple site. |
| Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day: 5, 21, and 42 | At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Absence of hematoma swelling at the staple site. |
| Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day: 5, 21, and 42 | At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: No need for re-intervention at the surgery site. |
| Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day: 5, 21, and 42 | At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Septum wall straight appearance. |
| Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | Day: 0 (Screening), 5, 21 and 42 | The Visual Analog Scale (VAS) for pain is a continuous scale completed by the participant who is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Scores range from 0-100 where a score of 0 represented no pain and a score of 100 indicated the worst pain possible. |
| Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | During procedure, up to 97 minutes | Intra-operative surgery duration overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in minutes between start of the procedure and when the drapes are removed from the patient. |
| Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | During procedure, up to 306 seconds | Intra-operative time to deploy staples overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in seconds between start of closure to when the stapler was handed back to the scrub nurse. |
| Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | Day: 0 (Screening), 5, 21 and 42 | The Nasal Obstruction Symptom Evaluation (NOSE) scale is a patient reported outcome (PRO). The NOSE Scale allows participants to quantify their symptoms based on the severity of their nasal obstruction/congestion. The NOSE score range was 0-100 were 0 represented no obstruction (i.e., better outcome) and 100 represented extreme obstruction (i.e., worse outcome). |
Countries
United States
Participant flow
Recruitment details
The enrollment for this study was conducted between 22 October 2020 and 25 June 2021 across three investigative sites.
Participants by arm
| Arm | Count |
|---|---|
| Device: ENTACT Septal Staple Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participant declined follow-up and subsequently withdrawn | 1 |
Baseline characteristics
| Characteristic | Device: ENTACT Septal Staple |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 18.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants |
| Race/Ethnicity, Customized Race Asian Indian | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants |
| Race/Ethnicity, Customized Race Bruneian | 0 Participants |
| Race/Ethnicity, Customized Race Cambodian | 0 Participants |
| Race/Ethnicity, Customized Race Chinese | 0 Participants |
| Race/Ethnicity, Customized Race Filipino | 0 Participants |
| Race/Ethnicity, Customized Race Indonesian | 0 Participants |
| Race/Ethnicity, Customized Race Japanese | 0 Participants |
| Race/Ethnicity, Customized Race Korean | 0 Participants |
| Race/Ethnicity, Customized Race Laotian | 0 Participants |
| Race/Ethnicity, Customized Race Malaysian | 0 Participants |
| Race/Ethnicity, Customized Race Myanmarese | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race Other Asian | 0 Participants |
| Race/Ethnicity, Customized Race Singaporean | 0 Participants |
| Race/Ethnicity, Customized Race Southeast Asian | 0 Participants |
| Race/Ethnicity, Customized Race Thai | 0 Participants |
| Race/Ethnicity, Customized Race Timor Lestian | 0 Participants |
| Race/Ethnicity, Customized Race Vietnamese | 0 Participants |
| Race/Ethnicity, Customized Race White | 37 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 4 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit
At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were YES then clinical success was inferred (if any answer was NO then repair failure was inferred).
Time frame: 21 days
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device: ENTACT Septal Staple | Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit | 94.7 percentage of participants |
Secondary
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
The Nasal Obstruction Symptom Evaluation (NOSE) scale is a patient reported outcome (PRO). The NOSE Scale allows participants to quantify their symptoms based on the severity of their nasal obstruction/congestion. The NOSE score range was 0-100 were 0 represented no obstruction (i.e., better outcome) and 100 represented extreme obstruction (i.e., worse outcome).
Time frame: Day: 0 (Screening), 5, 21 and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified. Last Observation Carried Forward (LOCF) method was only used to carry forward post-baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | Screening | 69.2 score on a scale | Standard Deviation 20.28 |
| Device: ENTACT Septal Staple | Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | Day 5 | 62.5 score on a scale | Standard Deviation 23.33 |
| Device: ENTACT Septal Staple | Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | Day 21 | 39.9 score on a scale | Standard Deviation 19.13 |
| Device: ENTACT Septal Staple | Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | Day 42 | 33.2 score on a scale | Standard Deviation 20.56 |
Secondary
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Absence of hematoma swelling at the staple site.
Time frame: Day: 5, 21, and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | Yes | 37 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | Yes | 39 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | No | 0 Participants |
Secondary
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Absence of significant local tissue reaction at the staple site.
Time frame: Day: 5, 21, and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | Yes | 35 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | No | 2 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | Yes | 39 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | No | 0 Participants |
Secondary
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Complete coaptation of perichondrial flaps on septum wall.
Time frame: Day: 5, 21, and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | Yes | 35 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | No | 2 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | Yes | 39 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | No | 0 Participants |
Secondary
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: No need for re-intervention at the surgery site.
Time frame: Day: 5, 21, and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | No | 0 Participants |
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | No | 1 Participants |
| Device: ENTACT Septal Staple | Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | Yes | 37 Participants |
Secondary
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: Septum wall straight appearance.
Time frame: Day: 5, 21, and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | Yes | 34 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 5 | No | 3 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | Yes | 36 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 21 | No | 2 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | Yes | 38 Participants |
| Device: ENTACT Septal Staple | Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | Day 42 | No | 1 Participants |
Secondary
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Intra-operative time to deploy staples overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in seconds between start of closure to when the stapler was handed back to the scrub nurse.
Time frame: During procedure, up to 306 seconds
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | Overall | 57.6 seconds | Standard Deviation 54.81 |
| Device: ENTACT Septal Staple | Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Turbinate Reduction and Sinus Surgery | 82.2 seconds | Standard Deviation 65.86 |
| Device: ENTACT Septal Staple | Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Turbinate Reduction | 28.1 seconds | Standard Deviation 12.06 |
| Device: ENTACT Septal Staple | Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Sinus Surgery and Turbinectomy | 125.0 seconds | Standard Deviation 22.63 |
| Device: ENTACT Septal Staple | Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | Septoplasty alone | 22.0 seconds | Standard Deviation 4.58 |
Secondary
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Intra-operative surgery duration overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in minutes between start of the procedure and when the drapes are removed from the patient.
Time frame: During procedure, up to 97 minutes
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | Overall | 43.7 minutes | Standard Deviation 27.88 |
| Device: ENTACT Septal Staple | Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Turbinate Reduction and Sinus Surgery | 64.9 minutes | Standard Deviation 23.23 |
| Device: ENTACT Septal Staple | Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Turbinate Reduction | 20.4 minutes | Standard Deviation 7.31 |
| Device: ENTACT Septal Staple | Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | Septoplasty with Sinus Surgery and Turbinectomy | 67.0 minutes | Standard Deviation 12.73 |
| Device: ENTACT Septal Staple | Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | Septoplasty alone | 25.0 minutes | Standard Deviation 15.72 |
Secondary
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
The Visual Analog Scale (VAS) for pain is a continuous scale completed by the participant who is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Scores range from 0-100 where a score of 0 represented no pain and a score of 100 indicated the worst pain possible.
Time frame: Day: 0 (Screening), 5, 21 and 42
Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified. Last Observation Carried Forward (LOCF) method was only used to carry forward post-baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device: ENTACT Septal Staple | Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | Screening | 9.6 score on a scale | Standard Deviation 19.82 |
| Device: ENTACT Septal Staple | Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | Day 5 | 13.9 score on a scale | Standard Deviation 20.92 |
| Device: ENTACT Septal Staple | Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | Day 21 | 6.0 score on a scale | Standard Deviation 12.4 |
| Device: ENTACT Septal Staple | Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | Day 42 | 2.0 score on a scale | Standard Deviation 5.78 |