Duet TRS Used in Pulmonary Resections | NCT01026025

Studies
Duet TRS Used in Pulmonary Resections

NCT01026025

Sponsor

Medtronic - MITG

Status

Withdrawn

Last Update Posted

Aug 7, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Duet TRS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor is no longer pursuing this study

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

May 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Dec 3, 2009

First Submission Date that Met QC Criteria

Dec 3, 2009

First Posted Date

Dec 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2013

Last Update Posted Date

Aug 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objectives of this clinical trial are to estimate 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 Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Duet TRS	Experimental	This is a single arm study.	Device: Duet TRS

Name	Type	Description	Arm Group Labels	Other Names
Duet TRS	Device	This is a single arm study.	Duet TRS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days)in an anatomic pulmonary resection.		intra-operative and 1 month follow up

Secondary Outcomes

Measure	Description	Time Frame
The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge.		discharge and 1 month follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

The patient is pregnant or breastfeeding
The patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease
The patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected
The patient is scheduled to receive intra-operative brachytherapy
The patient 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
The patient requires chest wall reconstruction

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess		Boston	Massachusetts	02118	United States
Boston Medical Center

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms