E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated 3. Patients eligible for anatomical or atypical pulmonary resection lobe resection bilobectomy typical segment resection wedge resection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024741 |
E.1.2 | Term | Lung lobectomy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to verify the efficacy and safety of IMP used for Aerostasis control in pulmonary resection surgery. |
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E.2.2 | Secondary objectives of the trial |
reduction of ospedalization |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 to 75 years old 2. Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated 3. Patients eligible for anatomical or atypical pulmonary resection lobe resection bilobectomy typical segment resection wedge resection 4. Open surgical access (standard thoracotomies, mini-thoracotomies, muscle preserving thoracotomies) 5. Life expectancy > six months 6. The subjects or their authorized legal representatives must have received adequate information regarding the nature of the trial, agree on study purposes, and have signed an informed consent form approved by the Ethical Committee. |
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E.4 | Principal exclusion criteria |
hypersensitivity to active substances or to any of the excipients and others similar products Parenchymal reseections with the use of thoracoscopy 2. Previous ipsilateral thoracotomies 3. Patients with lung cancer treated with neo-adjuvants (Chemotherapy or Radiotherapy) 4. Patients treated with Pneumonectomy 5. Karnofsky Performance Status (KPS) ≤50 6. Immunocompromised patients 7. Lab test results: Bilirubin >1.5 g/dl Alkaline phosphatase >120 iu/l Blood creatinine > 1.5 mg/dl WBC >10,000/mm3 8. Positive pregnancy test 9. Presence of any conditions which, in the investigators judgment, may interfere with study objective evaluation or with the patients participation in the study. 10. The patient refused to sign the written informed consent required for participation, or participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days). |
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E.5 End points |
E.5.1 | Primary end point(s) |
reduction of time the drainage is retained in each patient. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |