A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Launched by ETHICON ENDO-SURGERY · Feb 15, 2018
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
- • 2. Willingness to give consent and comply with all study-related evaluations and treatment 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 clinical study.
About Ethicon Endo Surgery
Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, is a leading global innovator in surgical devices and technologies, specializing in minimally invasive surgical solutions. With a commitment to advancing patient care, the company focuses on developing cutting-edge products that enhance surgical efficiency and improve patient outcomes. Ethicon Endo-Surgery conducts rigorous clinical trials to evaluate the safety and efficacy of its innovative devices, contributing to the evolution of surgical practices across various specialties. Through collaboration with healthcare professionals and ongoing research, the company aims to set new standards in surgical performance and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Birmingham, , United Kingdom
Yeovil, , United Kingdom
Glasgow, , United Kingdom
Edinburgh, , United Kingdom
Edinburgh, , United Kingdom
Patients applied
Trial Officials
Bruce Robb, MD
Principal Investigator
Indiana University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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