The HARMONIC 1100 Shears Study
Research type
Research Study
Full title
A Prospective, Single-Arm Multi-Center Study of the HARMONIC 1100 Shears and Generator G11 in Paediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynaecological, Urological, and Thoracic)
IRAS ID
319842
Contact name
Steve Leung
Contact email
Sponsor organisation
Ethicon Endo-Surgery, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study looks at the use of HARMONIC 1100 Shears, a medical device used for cutting and sealing blood vessels and tissue during various types of surgery. The performance of the device will be measured in terms of how well it seals (stops bleeding from) blood vessels that have been cut during surgery. The safety of the device will be assessed by looking at the number of adverse events related to the use of the device.
All potential participants will receive the same care and treatment whether on not they take part in the study. The only difference being that at study sites where the HARMONIC 1100 Shears are not routinely used, these will be used in place of the device(s) the surgeon normally uses for cutting and sealing.
REC name
South East Scotland REC 01
REC reference
23/SS/0008
Date of REC Opinion
16 Feb 2023
REC opinion
Further Information Favourable Opinion