A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

Study Overview
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Brief Summary
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This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal [GI], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.

Detailed Description
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The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.

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 Upper Gastrointestinal, Lower Gastrointestinal, and Gynecological Procedures

Conditions
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Upper GI; Lower GI; Gynecological

Intervention / Treatment
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* Device: ENSEAL X1 Curved Jaw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary laparoscopic or open procedure (upper gastrointestinal, lower gastrointestinal, or gynecological) where at least one vessel is planned to be transected by the ENSEAL X1 Curved Jaw device per the instructions for use; Willingness to give consent and comply with all study-related evaluations and visit schedule; and At least 18 years of age. Exclusion Criteria: Physical or psychological condition which would impair study participation; or 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: Upper Gastrointestinal/Lower Gastrointestinal/Gynecological<br>Any upper gastrointestinal/lower gastrointestinal/gynecological procedure where the ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use. | Device: ENSEAL X1 Curved Jaw<br>* ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Grade 3 or lower hemostasis 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 compression, monopolar device and/or touchups with ENSEAL X1; or Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of 5-point scale scores for various tasks completed by the ENSEAL X1 Curved Jaw device (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection) |  | Intraoperative | 
| Distribution of hemostasis grading scale for each vessel transected |  | Intraoperative | 
| Type, name, and number of additional hemostasis products required to achieve hemostasis for Grade 4 vessel transections |  | Intraoperative |