HARMONIC Focus (+) Shears Retrospective Study
Research type
Research Study
Full title
A Multicenter Retrospective Study of the HARMONIC Focus (+) Shears in Adult Urologic and Gynecologic Procedures and Pediatric Procedures
IRAS ID
299431
Contact name
Colin Cowan
Contact email
Sponsor organisation
Ethicon Endo-Surgery, Inc.
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
This study is a retrospective review of clinical data routinely recorded in the medical records of patients who previously had surgery where the HARMONIC Focus (+) Shears device was used. Data from adult patients who had urology or gynecology surgery, and paediatric patients who had any surgical procedure will be reviewed to assess the safety and performance of the HARMONIC Focus (+) Shears device.
This study involves analysis of existing data only. No prospective study procedures or data collection will be conducted.
Results Summary
This study was a review of medical records of adults and children who previously had surgery where the HARMONIC Focus (+) Shears device was used. The HARMONIC Focus (+) device is used during surgery to cut blood vessels and then seal them up again to prevent unnecessary blood loss. As such, this study looked at how much blood was lost during surgery and the number of patients that needed a blood transfusion. The study also looked at how long surgery took, the use of additional treatments to stop bleeding during surgery, length of hospital stay, and complications related to the HARMONIC Focus (+) device.The study was conducted based on the medical records of patients who underwent surgery where the HARMONIC Focus (+) was used at Children’s Hospital of Philadelphia USA, Freeman Hospital, Newcastle UK, and Istituto Nazionale Tumori Regina Elena di Roma, Rome Italy. Data from a total of 516 patients was included; 198 adults who had urology procedures, 25 adults who had gynaecoloy (women's health) procedures, and 293 children who had a variety of different types of surgery.
Of the 198 adults who had urology procedures, 35 (17.7%) received a blood transfusion. None (0.0%) of the 25 adults who had gynecology procedures or 293 children received blood transfusions. No blood transfusion were determined to be related to the HARMONIC Focus (+) device.
Adverse events (complications) considered as related, unknown, or possibly related to the HARMONIC Focus (+) device or surgical procedure were observed in 13 of 516 (2.5%) patients. A total of 2 of 198 adults who had urology surgery (1.0%), 0 of 25 adults who had gynaecology surgery (0.0%), and 11 of 293 children (3.8%) experienced these events.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0260
Date of REC Opinion
24 Aug 2021
REC opinion
Favourable Opinion