ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections

NCT01241617 | Terminated

• 1 other identifier: Juntendo-530
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.

Conditions

Lung Disease

Keywords

Lung disease; Lobectomy; Pulmonary resection

Outcome Measures

Primary Outcomes (1)

• Frequency of intraoperative air leak

  Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.

  Day 0

Secondary Outcomes (6)

• Postoperative duration of air leak

  Month 1 (Average time period)

• Duration of chest drainage

  Month 1 (Average time period)

• Frequency of intraoperative sealant use

  Day 0

• Incidence of intraoperative adverse events

  Day 0

• Incidence of postoperative adverse events

  Month 1 (Average time period)

Study Arms (2)

Duet TRS

ACTIVE COMPARATOR

Endo GIA with integrated Duet TRS

Device: Duet TRS

Endo GIA

ACTIVE COMPARATOR

Endo GIA stapler with Single Use Loading units

Device: Endo GIA

Interventions

Duet TRS DEVICE

Endo GIA stapler with integrated Duet TRS

Also known as: Endo GIA stapler with integrated Duet TRS

Duet TRS

Endo GIA DEVICE

Endo GIA stapler with Single Use Loading Units

Also known as: Endo GIA stapler with Single Use Loading Units

Endo GIA

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is between 20-79 years of age.
• The patient is eligible to be given pulmonary Lobectomy.
• The patient is scheduled to undergo pulmonary Lobectomy.
• Performance status 0\~1 (Eastern Cooperative Oncology Group classification).
• The patient has no history of lung surgery.
• The patient is healthy organ function.
• The patient is scheduled for surgery with staplers .
• The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

You may not qualify if:

• The patient has suffered thoracic trauma or has previously undergone pneumonectomy surgery.
• The patient has an active bacterial infection or fungal infection.
• The patient is undergoing continuing systemic administration (intravenous or oral) of steroids.
• The patient condition is complicated by uncontrolled diabetes mellitus.
• The patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
• The patient undergoes surgical procedure other than lobectomy during surgery.
• Reinforcement material other than the study materials are applied during surgery.
• The patient judged unsuitable for study participation by the investigator for any other reason.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Junendo University School of Medicine

Tokyo, Japan

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Kenji Suzuki, MD

  Juntendo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: November 16, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

JP (1)