E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative air leakage. |
perdite aeree postoperatorie |
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E.1.1.1 | Medical condition in easily understood language |
Leak of air after surgery pulmonary resection |
perdite di aria dopo intervento chirurgico di resezione polmonare |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066239 |
E.1.2 | Term | Mediastinal shift |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection. |
Valutare l’efficacia di Hemopatch rispetto a TachoSil in termini di durata delle perdite aeree postoperatorie in seguito a resezione polmonare. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of Hemopatch compared to TachoSil in postoperative application after pulmonary resection. |
Valutare la sicurezza di Hemopatch rispetto a TachoSil nell’applicazione postoperatoria in seguito a resezione polmonare. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Preoperative criteria • Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Video-Assisted Thoracoscopic surgery (VATS). • Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period. • If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study. Intraoperative criteria • Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing. |
Criteri preoperatori • Pazienti di età pari o superiore a 18 anni al momento della firma del modulo di consenso informato (informed consent form, ICF) sottoposti a intervento di resezione polmonare di elezione [lobectomia, segmentectomia o resezione atipica (“wedge resection”)], mediante toracotomia a cielo aperto o chirurgia toracoscopica video-assistita (Video Assisted Thoracoscopic surgery, VATS). • Pazienti o rappresentanti legalmente autorizzati in grado di rilasciare il proprio consenso informato in seguito a spiegazione dello studio proposto e disposti ad attenersi alle richieste dello studio inerenti la terapia durante l’intero periodo di trattamento dello studio. • I pazienti di sesso femminile in età fertile dovranno presentare un test di gravidanza sulle urine o sul sangue negativo, e dovranno acconsentire a utilizzare un metodo adeguato di controllo delle nascite per tutta la durata dello studio.
Criteri Intraoperatori • Pazienti con perdite aeree di grado 1 o 2 (scala di Macchiarini) in seguito a suturazione primaria meccanica e minima sutura manuale. |
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E.4 | Principal exclusion criteria |
Preoperative criteria • Patients who had previous lung surgery (on the same side) • Patients with an active, florid infection • Patients who have received chemotherapy within the previous 3 weeks. • Patients who have received radiation therapy within the previous 4 weeks. • Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin, collagen of any origin, NHS-PEG) • Patients undergoing emergency surgery • Patients on chronic use of steroids • Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period • Female patients who are nursing • Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit. • Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the investigator, could adversely affect patient's safety and/or compliance with study procedures • Patient is a family member or employee of the investigator Intraoperative criteria • Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy. • Patients who were treated with any surgical sealant • Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure • Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure |
Criteri preoperatori • Pazienti precedentemente sottoposti a intervento chirurgico polmonare (sullo stesso lato) • Pazienti con infezione attiva e florida • Pazienti sottoposti a chemioterapia nelle 3 settimane precedenti • Pazienti sottoposti a radioterapia nelle 4 settimane precedenti • Pazienti con ipersensibilità nota ai componenti del prodotto sperimentale e del controllo (fibrinogeno umano, trombina umana, collagene di qualsiasi origine, NHS-PEG) • Pazienti sottoposti a intervento chirurgico di emergenza • Pazienti che fanno uso cronico di steroidi • Pazienti di sesso femminile in età fertile con test di gravidanza positivo o che stanno programmando una gravidanza per il periodo dello studio clinico • Pazienti di sesso femminile in allattamento • Pazienti esposti a un altro farmaco o dispositivo sperimentale nell'ambito di uno studio clinico nei 30 giorni precedenti l’arruolamento o nei quali ciò sia previsto nei 30 giorni di durata dello studio, fino alla visita di fine studio • Pazienti nei quali coesistano condizioni mediche clinicamente rilevanti (ad es. malattie concomitanti, abuso di stupefacenti/alcolici) che, a giudizio dello sperimentatore, potrebbero influire negativamente sulla sicurezza e/o sull’aderenza del paziente alle procedure dello studio • Il paziente è un familiare o dipendente dello sperimentatore Criteri intraoperatori • Pazienti con complicanze gravi durante l’intervento chirurgico, inclusa la necessità di ricorrere ad adesiolisi e pneumonectomia • Pazienti trattati con un sigillante chirurgico di qualsiasi tipo • Complicanze intraoperatorie maggiori che richiedano rianimazione o deviazioni rispetto alla procedura chirurgica pianificata • Pazienti per i quali in sede intraoperatoria il chirurgo effettui riscontri di altro tipo che potrebbero precludere l’esecuzione della procedura dello studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection. |
Valutare l’efficacia di Hemopatch rispetto a TachoSil in termini di durata delle perdite aeree postoperatorie in seguito a resezione polmonare. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Air leakage will be assessed on the evening of the day of operation and subsequently at least twice daily (morning and evening) until chest drain removal. All patients will be followed up to 30 days postoperatively. |
La valutazione delle perdite aeree postoperatorie verrà eseguita la sera del giorno dell’intervento e successivamente almeno due volte al giorno (mattina e sera) fino alla rimozione del drenaggio toracico. Tutti i pazienti verranno sottoposti a follow-up postoperatorio per un periodo massimo di 30 giorni. |
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E.5.2 | Secondary end point(s) |
Incidence of intraoperative treatment failure • Incidence of patients with prolonged air leakage defined as air leakage > 5 days • Evaluation of hemostasis after application of product if bleeding at the surgical site occurs • The need for additional procedures (chest drainage, re-operation, respiratory assistance, and blood transfusion) • Time to chest tube removal • Time in surgery (minutes) from incision to closure • Length of stay in hospital (days) • Number of unplanned interventions within 30 days postoperatively • Incidence of adverse events (AEs) including pre-defined postoperative Adverse Events of Special Interest (AESIs) up to 30 ± 3 days after surgery: - Pneumothorax - Bronchopleural fistula - Emphysema (subcutaneous and mediastinal) - Pleural effusions - Postoperative respiratory failure - Empyema - Allergic reactions in reasonable temporal relationship with the product application • Number of patches used (for both investigational and control devices) • Vital signs and laboratory tests |
• Incidenza del fallimento terapeutico intraoperatorio • Incidenza di pazienti con perdita aerea prolungata, definita come perdita aerea di durata > 5 giorni • Valutazione dell’emostasi dopo l’applicazione del prodotto se si verifica un’emorragia nella sede chirurgica • Necessità di procedure supplementari (drenaggio toracico, reintervento, assistenza respiratoria e trasfusione ematica) • Tempo alla rimozione del tubo di drenaggio toracico • Durata dell’intervento (minuti) dall’incisione alla chiusura • Durata della degenza ospedaliera (giorni) • Numero di interventi non pianificati entro 30 giorni dall'intervento • Incidenza di eventi avversi (Adverse Events, AE), inclusi eventi avversi di particolare interesse (Adverse Events of Special Interest, AESI) postoperatori predefiniti, fino a 30 ± 3 giorni dopo l’intervento: - Pneumotorace - Fistola broncopleurica - Enfisema (sottocutaneo e del mediastino) - Versamenti pleurici - Insufficienza respiratoria postoperatoria - Empiema - Reazioni allergiche per le quali sussista una relazione temporale ragionevole con l’applicazione del prodotto • Numero di patch utilizzati (sia per il dispositivo sperimentale sia per il dispositivo di controllo) • Segni vitali ed esami di laboratorio
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoint will be assessed during surgery. |
gli endpoint secondary saranno valutati durante operazione |
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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 | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |