Enseal X1 Post Marketing Clinical Follow-up study
Research type
Research Study
Full title
A Prospective, Multi-Center Evaluation of the ENSEAL X1 \nLarge Jaw Tissue Sealer\n
IRAS ID
234608
Contact name
Jason Waggoner
Contact email
Sponsor organisation
Ethicon Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
This study is being done to collect performance and safety information relating to the ENSEAL X1 device. Information will be collected both during and after surgery.\n\nThe device is manufactured by the study Sponsor, Ethicon Endo-Surgery, Inc. It is approved for use in colectomy, gynecological and thoracic procedures in the countries where the study is taking place.\n\nApproximately 100 adult patients will be enrolled in this study at approximately 8 hospitals in the United States and United Kingdom. All patients participating in the study will have their surgery according to the surgeon’s standard practice using the ENSEAL X1 device. The selected surgeons already use the ENSEAL X1 device therefore there will be no difference to the way the surgery will be conducted. There is no additional procedure or testing required. \n\nPatient participation in this study is expected to last around 4 weeks. Final study visits will be the regularly-scheduled follow-up visits and will either be conducted in the hospital or on the telephone. This visit will take place approximately 4 weeks after surgery. \n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0063
Date of REC Opinion
20 Jun 2018
REC opinion
Further Information Favourable Opinion