NCT02652286

Brief Summary

Video-assisted thoracic surgery (VATS) anatomical lung resection provides an effective minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is associated with significantly less postoperative atrial fibrillation, blood transfusion, renal failure, and other complications when compared with lobectomy via thoracotomy. Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is not devoid of risk. Intra-operative surgical complications can be at times catastrophic. Complications include: pulmonary vascular injuries (Pulmonary artery (PA), pulmonary vein) necessitating urgent conversion to open thoracotomy and even death. Causes of conversion included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all tissue around PA branches is sometime difficult especially in the presence of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury. Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung resections were performed by VATS. The technical difficulty and danger of VATS lobectomy is directly related to PA branch manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the manipulation and dissection required by the surgeon on the PA branches, we can make these procedures safe and therefore more prevalent for anatomical pulmonary resections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P50-P75 for early_phase_1 lung-cancer

Timeline
Completed

Started Jan 2016

Shorter than P25 for early_phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

December 7, 2015

Last Update Submit

April 18, 2016

Conditions

Lung Cancer

Keywords

VATSEnergy sealing

Outcome Measures

Primary Outcomes (1)

  • All patients will be assessed for effective intra-operative pulmonary arterial branch vessel sealing. It will be measured visually by the presence or lack of vessel sealing failure

    All cases will be videotaped with a thoracosocpic 10 mm, 30 degree camera placed through the chest tube insertion site in order to evaluate the problems in cases of seal failure. All patients will have 4-0 prolene with SH needle ready for use on the sterile field in case there is a sealing failure that needs to be fixed. Additionally, all patients are routinely crossmatched for 2 units of packed red blood cells (as per standard pre-operative orders).

    30 days

Study Arms (1)

Harmonic Ace+7

OTHER

Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy

Device: HARMONIC ACE+7

Interventions

HARMONIC ACE+7DEVICE

Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy in humans

Harmonic Ace+7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients planned to undergo a VATS lobectomy at the CHUM-Hopital Notre-Dame

You may not qualify if:

  • Age \> 18 years old
  • Inability to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM-Notre Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Moishe Liberman, MD, PhD

    Centre Hospitalier de l'Université

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 11, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(1)