Clinical trials: Pulmonary Air Leaks
Pulmonary Air Leaks
Spiration Valves Against Standard Therapy
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions…
- Trial name
- VAST (NCT02382614)
- Testing
- Spiration Valve System
- Where
- 20 sites in United States
- Volunteers
- 75 people
- Sponsor
- Olympus Corporation of the Americas
Lung Disease, Pulmonary Lobectomy
PleuraSeal Post Market Study (Europe)
To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.
- Trial name
- NCT00704171
- Testing
- Standard Tissue Closure Techniques, PleuraSeal Lung Sealant System
- Where
- 9 sites in United States, Austria and 4 more
- Volunteers
- 121 people
- Sponsor
- Integra LifeSciences Corporation
Air Leak From Lung
Air Leak Detection and Treatment
Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary…
- Trial name
- CT0128 (NCT05854654)
- Testing
- Air Leaks
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Air Leak From Lung, Pneumothorax
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks.
- Trial name
- NCT06548386
- Testing
- Pleural gas analysis
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Lung Healing Technologies Inc
Postoperative Air Leak
Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks
The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery
- Trial name
- PLUG-I (NCT03905408)
- Testing
- 50 mL of 50% Glucose, 100 mL of 50% Glucose, 150 mL of 50% Glucose
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lung Diseases, Mesothelioma
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for…
- Trial name
- NCT02511600
- Testing
- Progel Sealant, Talcum Powder, Pain Questionnaire
- Sponsor
- M.D. Anderson Cancer Center
Open Thoracotomy
PleuraSeal Pivotal Study (US)
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy.
- Trial name
- NCT00748124
- Testing
- PleuraSeal Sealant System, Standard Tissue Closure Techniques
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- Integra LifeSciences Corporation
Air Leak From Lung
Pleurodesis Using Hypertonic Glucose
Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections.
- Trial name
- PLUG-II (NCT06293885)
- Testing
- Dextrose 50, Standard of Care - No Dextrose 50
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Post-operative Air Leaks
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
- Trial name
- NCT06934486
- Testing
- TissuePatch Sealant Film
- Volunteers
- 250 people
- Sponsor
- C. R. Bard
Postoperative Air Leaks in Risk Patients
Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells
The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for…
- Trial name
- CSM/FAP/2012 (NCT02045745)
- Testing
- Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Red de Terapia Celular
LUNG DISEASES
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.
- Trial name
- NCT02668978
- Testing
- Hemopatch™ Sealing Hemostat, Standard surgical technique
- Where
- Spain
- Volunteers
- 170 people
- Sponsor
- Quirón Madrid University Hospital
Lung Cancer, Lung Tumor
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
- Trial name
- NCT01394978
- Testing
- Control, ProGEL Pleural Air Leak Sealant with standard surgical closure, ProGEL Pleural Air Leak Sealant without standard surgical closure
- Where
- 18 sites in United States
- Volunteers
- 444 people
- Sponsor
- C. R. Bard
Air Leak From Lung
Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary…
- Trial name
- NCT03450265
- Testing
- Hemopatch, Tachosil
- Where
- 14 sites in Italy, Spain
- Volunteers
- 279 people
- Sponsor
- Baxter Healthcare Corporation
Air Leak From Lung, Lung Surgery
Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
Air leak from lung after major pulmonary resections is alveolar-pleural microfistulas resulting from damage to the visceral pleura during lung surgery.
- Trial name
- NODRAIN (NCT07350265)
- Testing
- No Intervention: Observational Cohort
- Where
- France
- Volunteers
- 100 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Lung Cancer
Evaluation of the Bio-Seal Biopsy Track Plug
The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air leaks, commonly associated with the…
- Trial name
- NCT00527722
- Testing
- Bio-Seal Track Plug, No lung plug
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- M.D. Anderson Cancer Center
Prolonged Air Leak, Postoperative Air Leak
Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection.
- Trial name
- NCT04065880
- Testing
- TachoSil®, Neoveil®
- Where
- Switzerland
- Volunteers
- 46 people
- Sponsor
- University Hospital, Basel, Switzerland
Pulmonary Disease, Chronic Respiratory Failure
Home Mechanical Ventilation Effectiveness and Air Leaks
Non invasive ventilation (NIV) usually presents air leaks that may determine the result of this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the adaptation period to NIV has not been…
- Conditions
- Pulmonary Disease, Chronic Respiratory Failure, COPD
- Trial name
- NCT01090986
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Air Leak From Lung
Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy…
- Trial name
- CT0136 (NCT05971719)
- Testing
- Air Leaks: Aerosol glycerine System
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Lung Surgery
Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection but also ... per- and post-operative air leaks.
- Trial name
- TENATAC (NCT06597604)
- Testing
- Intraoperative use of TenaTac in lung surgery, Intraoperative use of usual sealant in lung surgery
- Where
- 2 sites in France
- Volunteers
- 154 people
- Sponsor
- Hopitaux Prives de Metz, Groupe UNEOS