MedDataX Logo

Duet TRS Used in Pulmonary Resections

NCT ID: NCT01026025

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lobectomy segmentectomy pulmonary resection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duet TRS

This is a single arm study.

Group Type EXPERIMENTAL

Duet TRS

Intervention Type DEVICE

This is a single arm study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Duet TRS

This is a single arm study.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Covidien

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hiran C Fernando, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AS09003

Identifier Type: -

Identifier Source: org_study_id