The ENSEAL X1 Curved Jaw Tissue Sealer Study B
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 Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
IRAS ID
297543
Contact name
Steve Leung
Contact email
Sponsor organisation
Ethicon Endo-Surgery Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Research Summary:
This prospective, single arm, multi-centre study is being conducted to see how well the ENSEAL X1 Curved Jaw Tissue Sealer (ENSEAL X1) and Generator G11 device work in surgical procedures. 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 take part in the study if they have a medical condition requiring either a thoracic, urologic or Ear Nose and Throat (ENT) 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 surgeons routine practice. The only difference is that the surgeon will use the 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.
Its is hoped that a minimum of 105 participants across sites in the United States (US) and/or European Union and or United Kingdom and/or Japan will be enrolled in the study across the various thoracic, urologic and ENT procedures.Summary of Results:
One hundred and twelve (112) vessels were transected in 94 subjects. Hemostasis (grade 3 or lower) was achieved in 96.4% (108 vessels) (95% confidence interval (CI)I: 91.1- 99.0). The vast majority of vessels 104 (92.9%) transected were found to be Grade 1 (no bleeding at transection site), zero vessels Grade 2, four vessels (3.6%) Grade 3 and four (3.6%) vessels Grade 4. In the four vessels which had grade 4 hemostasis, the type of additional hemostatic measure(s) used to obtain hemostasis for Grade 4 Vessels were sutures (2; 50%) and hemoclips (2, 50%). Five (5) Grade 3/4 hemostasis events were detected among 14 enrolled ENT cases therefore enrollment was suspended for that subgroup and root cause analysis was conducted. A singular root cause was not identified for the Grade 3 or Grade 4 hemostasis events in the four ENT procedures. Hemostasis issues are likely due to multiple factors, including potential user factors. The complaint devices were not returned for investigation and based on review of the quality safety review there is no indication that the devices malfunctioned or performed abnormally.
Additional secondary performance endpoint analysis was conducted on ENSEAL X1 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). ENSEAL X1 device was used most often for tissue cutting (58; 61.7%), division of tissue bundles (57; 60.6%) and tissue dissection (52; 55.3%). Other usage tasks included adhesions removed or divided (13; 13.8%), lymphatics bundles divided (36; 38.3%), and tissue grasping (27; 28.7%).
Safety was evaluated by analyzing the number of device related adverse events (AE). Of the 94 completed subjects there were four subjects with at least one device related AE. One AE for thoracic and urologic and 2 ENT subjects. It was noted that two Grade 4 hemostatic subjects translated to two vascular AEs (1 Hematoma and 1 Venous hemorrhage).
In conclusion the data for ENSEAL X1 with GEN11 devices were shown to be safe and effective in the post-market setting. Regarding the ENT procedures, it was determined the device is operating as intended. The shaft length and pistol grip may not be optimal for open ENT procedures, and there is little evidence of surgeons using it for this indication outside the clinical study; therefore, the specific ENT indication is not medically relevant. Surgeons performing open head and neck procedures will select a device that is suitable for their surgical technique. It is recommended to collect additional Real-World Evidence and complaint data to best assess the device in open ENT surgery.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0103
Date of REC Opinion
10 May 2021
REC opinion
Further Information Favourable Opinion