NCT01241565

Brief Summary

The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as \> 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

3 active sites

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

October 18, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed
Last Updated

July 3, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

October 18, 2010

Results QC Date

March 31, 2014

Last Update Submit

June 3, 2014

Conditions

Lung Cancer

Keywords

lung cancerlobectomywedge resection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Prolonged Air Leaks

    Defined as \> 5 days by the Society for Thoracic Surgery

    Day 30

Secondary Outcomes (5)

  • Incidence of Air Leaks

    Day 30

  • Duration of Air Leak

    Day 30

  • Length of Hospital Stay

    Approximately Day 6

  • Duration of Chest Tube Following Surgery

    Approximately Day 5

  • Incidence of Serosal Tearing

    Day 30

Study Arms (1)

ENDO GIA™ Stapler with TRI-STAPLE™ Technology

EXPERIMENTAL

Single arm study, all patients will receive the study device.

Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Interventions

ENDO GIA™ Stapler with TRI-STAPLE™ TechnologyDEVICE

All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology

ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Eligibility Criteria

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

You may qualify if:

  • The subject must be 18 years of age or older.
  • The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.
  • The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.
  • The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.

You may not qualify if:

  • The subject is pregnant or breastfeeding.
  • The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.
  • The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.
  • The subject is scheduled to receive intra-operative brachytherapy.
  • The subject has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months.
  • Re-operative surgery is excluded if it is on the same side as the previous surgery.
  • Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
  • The subject is unable to comply with the follow-up visit schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedar Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Noreen Fahey
Organization
Covidien
noreen.fahey@covidien.com
203-821-4716

Study Officials

  • Robert McKenna, MD

    Cedar Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

October 18, 2010

First Posted

November 16, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

July 3, 2014

Results First Posted

July 3, 2014

Record last verified: 2014-06

Locations

US(3)