A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Upper Gastrointestinal/Lower Gastrointestinal/Gynecological 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
ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.
|
Outcome Measures
Primary Outcome Measures
- Achievement of Grade 3 or lower hemostasis for each vessel transection [Intraoperative]
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).
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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;
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Willingness to give consent and comply with all study-related evaluations and visit schedule; and
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At least 18 years of age.
Exclusion Criteria:
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Physical or psychological condition which would impair study participation; or
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Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Health | Charlotte | North Carolina | United States | 28204 |
| 2 | Gemelli Hospital | Rome | Italy | ||
| 3 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | ||
| 4 | Western General Hospital | Edinburgh | United Kingdom | ||
| 5 | Yeovil District Hospital | Yeovil | United Kingdom | BA21 4AT |
Sponsors and Collaborators
- Ethicon Endo-Surgery
Investigators
- Principal Investigator: Ahmar Shah, MD, Yeovil District Hospital
- Principal Investigator: Anna Fagotti, MD, Gemelli Hospital
- Principal Investigator: Sergio Alfieri, MD, Gemelli Hospital
- Principal Investigator: Richard Skipworth, MD, Royal Infirmary of Edinburgh
- Principal Investigator: Hugh Paterson, MD, Western General Hospital
- Principal Investigator: Keith Gersin, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENG_2019_01