Lung DiseaseNCT01241617
ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
A study testing Duet TRS and Endo GIA in people with Lung Disease, run by Medtronic - MITG at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Lung Disease
- What is being tested?
- Duet TRS and Endo GIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy
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.
Read the detailed description
Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.
Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.
Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material.
- Conditions
- Lung Disease
- Being tested
- Duet TRS, Endo GIA
- Keywords
- Lung disease, Lobectomy, Pulmonary resection
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duet TRSDevice
Also called Endo GIA stapler with integrated Duet TRS
Endo GIA stapler with integrated Duet TRS
Endo GIADevice
Also called Endo GIA stapler with Single Use Loading Units
Endo GIA stapler with Single Use Loading Units
| Study group | Role | What they receive |
|---|---|---|
| Duet TRS | Active comparator | Endo GIA with integrated Duet TRS Receives: Device: Duet TRS |
| Endo GIA | Active comparator | Endo GIA stapler with Single Use Loading units Receives: Device: Endo GIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of intraoperative air leak
Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.
Measured: Day 0
Secondary outcomes (6)
Postoperative duration of air leak
Duration of air leak will vary from patient to patient. Published literature states a duration of greater than 7 days occurs in 15% of patients.
Measured: Month 1 (Average time period)
Duration of chest drainage
Duration of chest drainage will vary from patient to patient.
Measured: Month 1 (Average time period)
Frequency of intraoperative sealant use
The need to use a sealant intraoperatively will be assessed for each patient during surgery.
Measured: Day 0
Incidence of intraoperative adverse events
The occurence of adverse events during surgery will be recorded for each patient.
Measured: Day 0
Incidence of postoperative adverse events
Patients are not required to return to the clinic at a specific time point. Any adverse events that occur after discharge will be captured.
Measured: Month 1 (Average time period)
Days of hospitalization
Discharge date will vary from patient to patient
Measured: Month 1 (Average time period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenji Suzuki, MD, Principal investigator, Juntendo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241617
- Sponsor's protocol ID
- Juntendo-530
- Status last verified
- Jan 2012
- First submitted
- 30 Jul 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy
- ClinicalTrials.gov ID
- NCT01241617
- Acronym / sponsor ID
- Juntendo-530
- Conditions
- Lung Disease
- Keywords
- Lung disease, Lobectomy, Pulmonary resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.
Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.
Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duet TRS | Active comparator | Device: Duet TRSEndo GIA with integrated Duet TRS |
| Endo GIA | Active comparator | Device: Endo GIAEndo GIA stapler with Single Use Loading units |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duet TRSAlso: Endo GIA stapler with integrated Duet TRSEndo GIA stapler with integrated Duet TRS | Device | Duet TRS |
| Endo GIAAlso: Endo GIA stapler with Single Use Loading UnitsEndo GIA stapler with Single Use Loading Units | Device | Endo GIA |
Primary outcome
Frequency of intraoperative air leak
Time frame: Day 0
Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.
6 secondary outcomes
Postoperative duration of air leak
Time frame: Month 1 (Average time period)
Duration of chest drainage
Time frame: Month 1 (Average time period)
Frequency of intraoperative sealant use
Time frame: Day 0
Incidence of intraoperative adverse events
Time frame: Day 0
Incidence of postoperative adverse events
Time frame: Month 1 (Average time period)
Days of hospitalization
Time frame: Month 1 (Average time period)
Results and safety
The study was stopped early (reason given: Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenji Suzuki, MD principal investigator
Juntendo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duet TRS and Endo GIA in people with Lung Disease, run by Medtronic - MITG at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of intraoperative air leak (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.