A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

Study Overview
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Brief Summary
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This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.

Detailed Description
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The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.

Official Title
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A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

Conditions
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Colectomy; Gynecological; Thoracic

Intervention / Treatment
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* Device: ENSEAL X1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use; Willingness to give consent and comply with all study-related evaluations and treatment schedule; and At least 18 years of age. Exclusion Criteria: Physical or psychological condition which would impair study participation; or Enrollment in a concurrent clinical study.

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: Colectomy/Gynecological/Thoracic<br>Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. | Device: ENSEAL X1<br>* ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | 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 monopolar device and/or touch-ups with ENSEAL X1; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative, after vessel has been transected | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis Grading Assessment for Each Vessel Transection | 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 monopolar device and/or touch-ups with ENSEAL X1; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative, after vessel has been transected | 
| Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | 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 monopolar device and/or touch-ups with ENSEAL X1; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative, after vessel has been transected | 
| Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | 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 monopolar device and/or touch-ups with ENSEAL X1; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative, after vessel has been transected |