Lung ResectionPhase 3NCT01349426
Ligasure II: Standard Stapling Versus Ligasure
A Phase 3 study testing LigaSure Force Triad Vessel Sealing System in people with Lung Resection, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
Trial summary
Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Resection
- What is being tested?
- LigaSure Force Triad Vessel Sealing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 10 sitesFrance
- Study dates
- Sep 2010to Feb 2015
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Patients scheduled for thoracotomy, lobectomy or bilobectomy
- Patients must give informed consent
Who cannot join
- Patient is unwilling or unable to provide informed consent
- Patients who can not tolerate thoracotomy
- Patients who require extensive dissection to release adhesions which may result in air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by the devices in question
- Patients with no parenchymal bridge between lobes; 100% complete fissure.
- Patients with complete incomplete fissure with a thickness > 1.5 cm measure intraoperatively
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital
Bron
CHU Clermont Ferrand - Service of Thoracic Surgery
Clermont-Ferrand
CHU Grenoble - Department of Vascular and Thoracic Surgery
Grenoble
CHU Lille - Service of Thoracic Surgery
Lille
Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery
Limoges
CHU Marseille - Department of Thoracic Surgery
Marseille
CHU Nice - Pasteur Hospital - Department of Thoracic Surgery
Nice
Chu Saint-Etienne
Saint-Etienne, 42100
CHU Strasbourg - Service of Thoracic Surgery
Strasbourg
Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse
Toulouse
About this study
Official title: Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial
Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.
- Conditions
- Lung Resection
- Being tested
- LigaSure Force Triad Vessel Sealing System
- Keywords
- Lung resection, Parenchymal pneumostasis, haemostasis, Fissure closure, Automatic staplers,LigaSure, Force Triad Generator, Bipolar fusion, Procedure cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSure Force Triad Vessel Sealing SystemDevice
Also called Automatic Staplers TA30P, TA55, Endo GIA II MULTIFIRE
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
| Study group | Role | What they receive |
|---|---|---|
| LigaSure | Experimental | * Arm 1
* Patients undergoing lung surgery Receives: Device: LigaSure Force Triad Vessel Sealing System |
| Automatic Staplers | Active comparator | * Arm 2
* Patients undergoing lung surgery Receives: Device: LigaSure Force Triad Vessel Sealing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of post-operative air leak between the two techniques
Measured: Day 1
Secondary outcomes (2)
Compare the number of lung stitches between LigaSure device and standard staplers
Measured: Day 1
Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: diffculty to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung ResectionStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- TIFFET Olivier, MD, Principal investigator, CHU Sainte-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349426
- Sponsor's protocol ID
- 1008067
- Other IDs
- 2010-A00666-33
- Status last verified
- Jul 2015
- First submitted
- 4 May 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01349426
- Acronym / sponsor ID
- 1008067
- Conditions
- Lung Resection
- Keywords
- Lung resection, Parenchymal pneumostasis, haemostasis, Fissure closure, Automatic staplers,LigaSure, Force Triad Generator, Bipolar fusion, Procedure cost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: diffculty to include patients
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Sep 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 May 2011 (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.
Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LigaSure | Experimental | Device: LigaSure Force Triad Vessel Sealing System* Arm 1 * Patients undergoing lung surgery |
| Automatic Staplers | Active comparator | Device: LigaSure Force Triad Vessel Sealing System* Arm 2 * Patients undergoing lung surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients scheduled for thoracotomy, lobectomy or bilobectomy
- Patients must give informed consent
Key exclusion criteria (5 listed)
- Patient is unwilling or unable to provide informed consent
- Patients who can not tolerate thoracotomy
- Patients who require extensive dissection to release adhesions which may result in air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by the devices in question
- Patients with no parenchymal bridge between lobes; 100% complete fissure.
- Patients with complete incomplete fissure with a thickness > 1.5 cm measure intraoperatively
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 |
|---|---|---|
| LigaSure Force Triad Vessel Sealing SystemAlso: Automatic Staplers TA30P, TA55, Endo GIA II MULTIFIREQuality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers | Device | Automatic Staplers, LigaSure |
Primary outcome
Rates of post-operative air leak between the two techniques
Time frame: Day 1
2 secondary outcomes
Compare the number of lung stitches between LigaSure device and standard staplers
Time frame: Day 1
Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.
Time frame: Day 1
Results and safety
The study was stopped early (reason given: diffculty to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
TIFFET Olivier, MD principal investigator
CHU Sainte-Etienne
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LigaSure Force Triad Vessel Sealing System in people with Lung Resection, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
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 3 inclusion and 5 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: diffculty to include patients). 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?
Rates of post-operative air leak between the two techniques (time frame: Day 1). 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 28 Jul 2015.