The ENSEAL X1 Curved Jaw Tissue Sealer Study
Research type
Research Study
Full 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
IRAS ID
286688
Contact name
Ahmar Shah
Contact email
Sponsor organisation
Ethicon Endo-Surgery Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Research Summary
This prospective, single-arm, multi-center study is being conducted to see how well two standard-of-care instruments, the ENSEAL X1 Curved Jaw Tissue Sealer (“ENSEAL X1”) and the Generator G11 device, work in surgical procedures involving the cutting and sealing of blood vessels. The ENSEAL X1 device is a surgical instrument used to cut and seal blood vessels, and cut, grasp, and dissect tissue during surgery. The Generator G11 device provides power to operate the ENSEAL X1 device.
Potential participants may be invited to the study if they have a medical condition requiring either a gastrointestinal (GI) or gynecological surgical procedure where the study device is used for the cutting and sealing of blood vessels.
All participants taking part in the study will have surgery according to their surgeon’s routine practice. The only difference is that the surgeon will use the ENSEAL X1 device to cut and seal blood vessels, and cut, grasp, and dissect tissue during surgery in place of the device they would normally use. There are no additional medical procedures or tests required by participants.
It is hoped that a minimum of 164 patients (max. 180) across centers in the United States and/or European Union and/or United Kingdom will be enrolled in the study across various upper GI, lower GI and gynecological procedures.Summary of results
The primary objective of this study was continued evaluation of the safety and performance of the ENSEAL X1 Curved Jaw and GEN11 Generator devices when used per the instructions for use (IFU).Performance was assessed by observing achievement of hemostasis (cessation of bleeding from a bloodvessel) for each vessel transection. Safety was evaluated by the occurrence of device-related adverse events (AEs). A total of 145 subjects met inclusion/exclusion criteria and were enrolled in the study. No subject discontinued the study prior to study closure. The primary endpoint evaluated was the number and percentage of vessels achieving (less than or equal to Grade 3) hemostasis using a Grade 1-4 scale.Grade1:no bleeding at transection site;Grade2:minor bleeding at transection site no intervention; Grade 3: minor bleeding at transection site, mild intervention needed; or Grade 4: significant bleeding requiring intervention. There were a total of 279 vessel transections in the full analysis set. Of the 279,100% of the vessel transections achieved a grade 3 or lower hemostasis score with a 95% confidenceinterval (98.69%-100.00%). One-hundred and twenty-one (121) transections were performed in theupper GI and 49 and 109 transections performed in the lower GI and gynecological procedure groups,respectively. Secondary endpoints in the clinical evaluation also measured the distribution for varioustasks completed by the ENSEAL X1 Curved Jaw device and distribution of hemostasis grading scale (1-4)for each vessel transected. The vast majority of vessels, 258 (92.5%) transected were found to be Grade1 (no bleeding at transection) site, 12 (4.3%) vessels Grade 2, nine vessels (3.2%) Grade 3 and zerovessels Grade 4. Additional secondary performance endpoint analysis was conducted on ENSEAL X1Curved usage to determine the distribution of 5-point scale scores for various tasks completed by the ENSEAL X1 device (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection). The ENSEAL X1 Curved device was used most often for tissue dissection 107 (73.8%),tissue cutting 87 (60.0%) and tissue grasping 67 (46.2%). Other usage tasks included division of tissue bundles 55 (37.9%), adhesions removed or divided 49 (33.8%), and lymphatics bundles divided 27(18.6%). Overall surgeon satisfaction was high (more than 80% rated satisfied/very satisfied) across all usage types with 98.2% satisfied or very satisfied for tissue bundle division by ENSEAL X1 Curved,98.0% of surgeons were satisfied or very satisfied with the adhesion removal or division and 97.2% of surgeons were satisfied or very satisfied with the tissue dissecting by ENSEAL X1 Curved. Investigators were asked to answer a non-validated surgeon questionnaire related to the performance the GEN 11generator. Majority of surgeons (98.6%) Strongly agree/agreed the generator performed as intended. No generator related alarms were noted in 97.9% of subjects. Safety was evaluated by analyzing the occurrence of device related (possibly, probably, or causally) adverse events (AEs). The total number of AEs related to the study device was two, one in the upper gastrointestinal procedure group and one in the gynecological procedure group. Both AEs were deemed “possibly” related. The upper gastrointestinal subject’s AE was decreased hemoglobin, and the gynecological subject AE was an abdominal hemorrhage. In conclusion the data demonstrated ENSEALX1 Curved with GEN11 devices to be safe and effective in the post-market setting.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/1135
Date of REC Opinion
12 Nov 2020
REC opinion
Further Information Favourable Opinion