VATS PA-ACE STUDY
Research type
Research Study
Full title
Prospective, Multi-Center, International Phase 2 Trial of the use of Ultrasonic Energy for Pulmonary Artery Branch Sealing during VATS Lobectomy and Cost Effectiveness Study
IRAS ID
233397
Contact name
Joel Dunning
Contact email
Sponsor organisation
Centre Hospitalier de l'Université de Montréal
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
To perform a minimally invasive pulmonary lobectomy, surgeons must seal and cut the branches of the pulmonary artery attached to the lobe being removed. The pulmonary artery is a fragile blood vessel at risk for damage when handled during surgery. The usual instrument used to seal and cut the branches of the pulmonary artery is called a mechanical vascular stapler. This instrument is rigid and bulky to use, which can lead to injury to a branch of the pulmonary artery and cause bleeding during the operation. Other instruments to seal and cut blood vessels are called energy-sealing devices and are more delicate than mechanical vascular staplers. These energy-sealing devices, such as the instrument used for this study, the Harmonic ACE+7, are currently used in other types of surgeries, but are not broadly used among thoracic surgeons to seal and cut branches of the pulmonary artery. Researchers think these energy-sealing devices provide the technical advantage of being easier to use than mechanical staplers to perform minimally invasive pulmonary lobectomy.
Patients scheduled for a minimally invasive anatomical lung resection are eligible to this trial. Participants will have pulmonary arteries of 7 mm or less in diameter sealed and cut with the Harmonic ACE+7 instead of mechanical vascular staplers. The Harmonic ACE+7 is an approved device for sealing and cutting any blood vessel of 7 mm or less. The remainder of the surgery will follow the surgeon's standard of care.REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0011
Date of REC Opinion
26 Jan 2018
REC opinion
Favourable Opinion