A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

NCT03056300 | Completed Results

• 1 other identifier: ESC-14-006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Intra-Operative Hemostatic Interventions

  Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).

  Intra-Operative

• Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding

  Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).

  Post-op through 4 week follow-up

Study Arms (1)

Powered vascular stapler

EXPERIMENTAL

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Interventions

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler DEVICE

Powered Vascular Stapler used on vessels

Powered vascular stapler

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
• Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
• Performance status 0-1 (Eastern Cooperative Oncology Group classification);
• ASA score \< 3;
• No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);
• Willing to give consent and comply with study-related evaluation and treatment schedule; and
• years of age (inclusive).

You may not qualify if:

• Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
• Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
• Uncontrolled diabetes mellitus;
• End stage renal or liver disease;
• History of severe cardiovascular disease;
• FEV1% \<50% or severe COPD;
• Prior chemotherapy or radiation for lung cancer;
• Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
• Robotic-assisted procedure;
• Women who are pregnant or lactating at the time of screening;
• Physical or psychological condition which would impair study participation;
• The subject is judged unsuitable for study participation by the Investigator for any other reason;
• Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
• Unable or unwilling to attend follow-up visits and examinations.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This was a single arm study with a limited sample size.

Results Point of Contact

• Title: Michael Schwiers
• Organization: Ethicon

mschwier@its.jnj.com

513-337-1172

Study Officials

• Keneng Chen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Shugeng Gao

  Cancer Institute and Hospital, Chinese Academy of Medical Services

  PRINCIPAL INVESTIGATOR

• Hu Jian

  The first affiliated hospital Zhejiang University/Hangzhou

  PRINCIPAL INVESTIGATOR

• Li Jian

  Beijing Friendship hospital/Hangzhou

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 17, 2017
• Study Start: January 11, 2017
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: January 30, 2019
• Results First Posted: December 17, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)