Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
IRAS ID
200064
Contact name
Erin Creedon
Contact email
Sponsor organisation
ETHICON Endo-Surgery, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 17 days
Research summary
The primary objective of the study is to demonstrate that the frequency of treatments to control bleeding required during surgery or after surgery related to the cutting of the pulmonary artery (PA) and pulmonary vein (PV) during VATS lobectomy with ECHELON FLEX powered vascular stapler (PVS) is not increased when compared to standard of care (SOC).\n\nPatients will be reviewed approximately 1-2 weeks before surgery, on their surgery date, at hospital discharge and a final visit (telephone or clinic) 4 weeks after surgery.\n\nAfter the surgery, the focus of the study is the collection of safety information in the form of adverse events and any medications used to treat them. Patients will be asked to complete a pain score questionnaire at discharge and at the 4-week follow up visit.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0138
Date of REC Opinion
18 Mar 2016
REC opinion
Further Information Favourable Opinion