Ultrasonic Energy for Pulmonary Artery Branch Sealing During VATS Lobectomy

Overview

About this study

This research program consists of a prospective, multi-institutional Phase 2 trial and an economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy compared to traditional techniques. It will be left up to the study credentialed surgeon investigator to decide the suitability of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular dissection and length as well as patient specific factors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Ability to consent
  2. > 18 years old
  3. Non-hilar tumors
  4. Pre-operative imaging (chest CT and PET-CT
  5. Invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound.

Exclusion Criteria:

  1. Previous unilateral thoracic surgical procedure or trauma
  2. History of mediastinal or pulmonary irradiation
  3. Anticoagulation with inability to stop anticoagulants prior to surgery
  4. Systemic vascular disease or vasculitis
  5. Uncorrectable coagulopathy
  6. Use of systemic steroids or immunosuppressive medication Pulmonary hypertension will not be an exclusion criterion as patients with pulmonary hypertension were shown to have higher bursting pressures following PA sealing in previous studies.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Closed for enrollment

More information

Publications

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Study Results Summary

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Supplemental Study Information

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Additional contact information

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Phone: 800-664-4542 (toll-free)

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