E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative air leakage. |
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E.1.1.1 | Medical condition in easily understood language |
Leak of air after surgery pulmonary resection |
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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 | 10067826 |
E.1.2 | Term | Pulmonary air leakage |
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. |
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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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Preoperative
• 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
• Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing. |
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E.4 | Principal exclusion criteria |
Preoperative
• 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
• 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for assessing the efficacy of Hemopatch compared to TachoSil is the duration of patients’ postoperative air leakage, measured in days. |
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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. |
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E.5.2 | Secondary end point(s) |
The secondary endpoints to assess the safety of Hemopatch compared to TachoSil are:
• 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 (days)
• 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 AEs of special interest up to 30 ± 3days 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoint will be assessed during surgery. |
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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 | 9 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |