A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).

Official Title
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A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

Conditions
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Thoracic Procedure, Urologic Procedure, Ear, Nose and Throat Procedure

Intervention / Treatment
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* Device: ENSEAL X1 Curved Jaw Tissue Sealer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat [ENT]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU) Willingness to give consent and comply with all study-related evaluations and treatment schedule At least 18 years of age Exclusion Criteria: Physical or psychological condition which would impair study participation Enrollment in a concurrent interventional clinical study that could impact the study endpoints

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures<br>Any thoracic, urologic, or ENT procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Participants will be considered enrolled when the ENSEAL X1 device has been attempted to be used for a vessel transection during thoracic, urologic, or ENT procedures. | Device: ENSEAL X1 Curved Jaw Tissue Sealer<br>* ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved <=Grade 3 hemostasis was reported. | On the day of transection (Day 0) | 
| Number of Participants With at Least One Device-related Adverse Events (AEs) | Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use. | Baseline up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatics bundles division by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue bundles division by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue grasping by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue cutting by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissue dissection by ENSEAL X1. | On the day of transection (Day 0) | 
| Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale | A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). Here, the number of vessels that achieved Grade 1 to 4 hemostasis was reported. | On the day of transection (Day 0) | 
| Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips | Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported. | On the day of transection (Day 0) |