Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01867658
Eligibility Criteria:
Inclusion Criteria:
* Subject is willing and able to provide written informed consent.
* Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation.
* Subject is ≥18 years of age.
* Subject has a life expectancy ≥6 months.
* Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied, that requires treatment with pleural sealant.
* Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.
Exclusion Criteria:
* Subject has undergone previous lung resection or previous use of a sealant for air leaks.
* Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
* Following lung resection, subject has intraoperative air leaks that require non-standard, visceral pleural closure (e.g. leak is too small or tissue is too fragile to use sutures/staples).
* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
* Subject has known allergy to human albumin or any component in the Progel® PALS product.
* Subject has an active or latent infection which is systemic or at the intended surgery site.
* Subject has necrotic or friable borders of the defect that will not support secure suture fixation if use of sutures is required.
* Subject is participating in another investigational drug or device trial.
* Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
* Subject is part of the site personnel directly involved with this study.
* Subject is a family member of the investigational study staff.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01867658
Study Brief:
Protocol Section:
NCT01867658