Clinical trial · Interventional
Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears(HS) for VATS Lobectomy
Ex-Vivo Evaluation of the Effectiveness of Pulmonary Artery Sealing Using the HARMONIC ACE + Shears (HS) for VATS Lobectomy
- 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)
VATS anatomical lung resection provides an effective minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is associated with significantly less postoperative atrial fibrillation, blood transfusion, renal failure, and other complications when compared with lobectomy via thoracotomy. Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is not devoid of risk. Intra-operative surgical complications can be at times catastrophic. Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. The technical difficulty and increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation and this is the main limitation for many thoracic surgeons regarding the adoption of VATS lobectomy into their practise. Furthermore, the majority of VATS lobectomies are being performed in high volume, academic medical centers with a resultant disparity in socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a way to decrease the manipulation required by the surgeon on the PA branches, these procedures will be safer, less stressful for the surgeon and therefore more prevalent for anatomical pulmonary resections.
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 |
|---|---|---|---|
| HARMONIC ACE®+ Shears (HS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Pulmonary artery Energy Sealing with HARMONIC ACE+ Shears (HS) ex-vivo
- interventionNames
- Device: HARMONIC ACE®+ Shears (HS)
Primary outcomes (1)
- measure
- Primary outcome for analysis will be the intergroupe comparison of mean PA burst pressures.
- timeFrame
- 5 months
- description
- Intergroup differences will be compared with the student's t-test with bursting pressures entered as a continuous variable. Statistical testing for normality of data will be performed and when data is non-normal, non-parametric methods (ex: Wilcoxon Rank Sum Test…) will be used. Multivariable linear regression models will be employed in order to compare burst pressures between groups controlling for potential confounders (disease state, size of vessel sealed, age of patient, sex, pulmonary lobe, laterality, immunosupression, diabetes, vascular disease…).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients with non-hilar tumours undergoing anatomical pulmonary lung resection by either VATS or open thoracotomy, 2. patients undergoing lung explant prior to lung transplantation and 3. patients undergoing multiple visceral organ retrieval in which the lungs are not suitable for transplant. Exclusion criteria: * inability to consent (patient or family member in case of recipient organ), * patient \< 18 years old, * patients with hilar tumours in proximity to major PAs that might affect the integrity of the pathological vascular margin.
References
Publications (0)
Data not yet available