ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
This study has been completed.
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01241565
First received: October 18, 2010
Last updated: January 10, 2012
Last verified: January 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection |
Resource links provided by NLM:
Further study details as provided by Covidien:
Primary Outcome Measures:
- Incidence of prolonged air leaks, defined as > 5 days by the Society for Thoracic Surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of air leaks as recorded on the daily air leak assessment form [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Duration, as measured in days, of air leaks as recorded on the daily air leak assessment form. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Duration of chest tube following surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Incidence of serosal tearing [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Single arm study, all patients will receive the study device.
|
Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241565
Locations
| United States, California | |
| Cedar Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Illinois | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Covidien
Investigators
| Principal Investigator: | Robert McKenna, MD | Cedar Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT01241565 History of Changes |
| Other Study ID Numbers: | COVEGTT0027 |
| Study First Received: | October 18, 2010 |
| Last Updated: | January 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Covidien:
|
lung cancer lobectomy wedge resection |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013