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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: ENTACT Septal Staple | Septoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENTACT Septal Staple system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day: 5, 21, and 42 |
| Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) |
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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:
Exclusion Criteria:
The patient will be ineligible for the study if he or she meets any of the following exclusion criteria at the baseline screening or during surgery:
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Population needing septoplasty
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| Name | Affiliation | Role |
|---|---|---|
| Sharron E McCulloch, MS | Smith & Nephew, Inc. | Study Director |
| Stephan Mangin | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT and Allergy Associates of Florida | Boca Raton | Florida | 33487 | United States | ||
| South Florida Sinus and Allergy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24039176 | Background | Sowerby LJ, Wright ED. A comparison of septal stapler to suture closure in septoplasty: a prospective, randomized trial evaluating the effect on operative time. Int Forum Allergy Rhinol. 2013 Nov;3(11):911-4. doi: 10.1002/alr.21209. Epub 2013 Aug 26. |
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The enrollment for this study was conducted between 22 October 2020 and 25 June 2021 across three investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All participants enrolled in the study (i.e., received the study device).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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:
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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days |
|
Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PURULENT DRAINAGE OVER LEFT ANTERIOR ETHMOID | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated to device |
No limitations reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Horner | Smith+Nephew, Inc | +44 1482 673251 | judith.horner@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2020 | Jan 6, 2022 | Prot_SAP_000.pdf |
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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. |
| Day: 5, 21, and 42 |
| 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. | Day: 5, 21, and 42 |
| 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. | Day: 5, 21, and 42 |
| 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. | Day: 5, 21, and 42 |
| 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). | Day: 0 (Screening), 5, 21 and 42 |
| 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. | Day: 0 (Screening), 5, 21 and 42 |
| 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. | During procedure, up to 97 minutes |
| 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. | During procedure, up to 306 seconds |
| Fort Lauderdale |
| Florida |
| 33301 |
| United States |
| Beacon Medical Group Specialist | Elkhart | Indiana | 46514 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day: 5, 21, and 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day: 5, 21, and 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day: 5, 21, and 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day: 5, 21, and 42 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day: 5, 21, and 42 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Day: 0 (Screening), 5, 21 and 42 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Day: 0 (Screening), 5, 21 and 42 |
|
|
|
| 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. | 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. | Posted | Median | Standard Deviation | minutes | During procedure, up to 97 minutes |
|
|
|
| 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. | 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. | Posted | Median | Standard Deviation | seconds | During procedure, up to 306 seconds |
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| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
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| COVID-19 | General disorders | Systematic Assessment | Unrelated to device |
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| COUGH | General disorders | Systematic Assessment | Unrelated to device |
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| FATIGUE | General disorders | Systematic Assessment | Unrelated to device |
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| RIGHT NASAL SCAR BAND | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated to device |
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| EPISTAXIS | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated to device |
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| Title | Measurements |
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| Day 42 |
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| Title | Measurements |
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| Day 42 |
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| Septoplasty with Turbinate Reduction |
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| Septoplasty with Sinus Surgery and Turbinectomy |
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| Septoplasty alone |
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| Septoplasty with Turbinate Reduction |
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| Septoplasty with Sinus Surgery and Turbinectomy |
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| Septoplasty alone |
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