Clinical trial NCT04763421: A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper GI; Lower GI; Gynecological
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
3. At least 18 years of age.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation; or
2. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

Primary outcomes:
measure: Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Device-related Adverse Events (AEs)
timeFrame: From Day 0 up to post-procedure follow up visit (up to 28 days)
Secondary outcomes:
measure: Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures
timeFrame: On the day of transection (Day 0)
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Rome
country: Italy
facility: Gemelli Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: Yeovil District Hospital
name: Ahmar Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gemelli Hospital
name: Anna Fagotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gemelli Hospital
name: Sergio Alfieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Infirmary of Edinburgh
name: Richard Skipworth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western General Hospital
name: Hugh Paterson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Keith Gersin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southmead Hospital
name: James Hopkins, MD
role: PRINCIPAL_INVESTIGATOR
References: