Clinical trial · Interventional
ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objectives of this clinical trial are to compare 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™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENDO GIA™ Stapler with TRI-STAPLE™ Technology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ENDO GIA™ Stapler with TRI-STAPLE™ Technology
- description
- Single arm study, all patients will receive the study device.
- interventionNames
- Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Primary outcomes (1)
- measure
- Incidence of Prolonged Air Leaks
- timeFrame
- Day 30
- description
- Defined as \> 5 days by the Society for Thoracic Surgery
Secondary outcomes (5)
- measure
- Incidence of Air Leaks
- timeFrame
- Day 30
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject must be 18 years of age or older. * The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer. * The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure. * The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent. Exclusion Criteria: * The subject is pregnant or breastfeeding. * The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease. * A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary. * The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected. * The subject is scheduled to receive intra-operative brachytherapy. * The subject 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. * Investigator determines that participation in the study may jeopardize the safety or welfare of the subject. * The subject is unable to comply with the follow-up visit schedule
References
Publications (0)
Data not yet available