NCT00704171已完成4 期
Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 10
- 主要终点
- Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age or older
- •Scheduled for an elective pulmonary lobectomy and segmentectomy (limited resection in case of reduced functional operability) in one or more lobes via an open thoracotomy
- •Subject or authorized representative has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Ethics Committee of teh respective clinical site
- •Pre-Operative
排除标准
- •Documented history of bleeding disorders and/or severely altered renal or hepatic function
- •Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, immunosuppressive therapy)
- •Prior ipsilateral thoracotomy
- •Subject with Tuberculosis
- •Extensive adhesions from previous thoracic trauma or surgery
- •Undergoing lung volume reduction surgery, wedge resection, pneumonectomy, sleeve resection or bronchoplasty, blebectomy, bullectomy, pleurodesis, lung transplant, or living lobe transplant donor
- •Subject has active systemic or pulmonary infection
- •Treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks
- •Pregnant (documented by pregnancy test), breast-feeding, or that wish to become pregnant during the course of the study or not willing to use birth control (e.g. IUD; oral, transdermal or parenteral contraceptives; abstinence)
- •Documented history of uncontrolled diabetes
- •Subject has an estimated life expectancy of less than 6 months
- •Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
- •Congestive heart failure, cor pulmonale, or other condition that, in the opinion of the investigator, may jeopardize the subject's well-being and/or negatively impact the interpretation of data collected during the clinical study
- •Unable to comply with the study requirements or follow-up schedule
- •Intra-Operative Inclusion Criteria:
- •At least one intra-operative air leak identified during lung submersion leak test after the initial closure is completed
- •Hemostasis must be confirmed prior to randomization
- •Intra-Operative Exclusion Criteria:
- •Procedure performed via VATS only
- •Air leaks originating from bronchioles >1 mm in diameter that cannot be primarily closed or a residual tidal volume loss of >=30%
- •Extensive intra-thoracic adhesions present
- •Exploratory thoracotomy performed only
- •Pneumonectomy, wedge resection, sleeve resection, pleurodesis, bronchoplasty, blebectomy or bullectomy performed
- •Incidental finding of any other pre-operative exclusion criteria
- •Use of buttressing materials or other non-autologous staple/suture line reinforcement or other surgical sealants when used for pulmonary sealing (i.e., use of hemostatic agents for hemostasis is permitted); however, the sealant should not be applied over intact hemostatic material and all hemostat should be removed prior to sealant application
- •Investigator determines that participation in the study may jeopardize the safety or welfare of the subject
结局指标
主要结局
Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.
时间窗: 30 days
Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge
时间窗: 30 days
Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles
次要结局
- Duration of Hospitalization(30 days)
- Time From Skin Closure to Last Observable Air Leak.(30 days)
- Duration of Chest Drainage(30 days)
- Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.(Intra-operatively, time of study procedure)
研究者
研究点 (10)
Loading locations...
相似试验
终止
3 期
PleuraSeal Pivotal Study (US)Open ThoracotomyNCT00748124Integra LifeSciences Corporation230
Unknown
不适用
Standard of Care Versus Hemopatch® During Liver ResectionHemorrhage LiverBile LeakSurgeryTumor LiverLiver CancerNCT03166683Fundación Pública Andaluza para la gestión de la Investigación en Sevilla284
终止
不适用
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced EmphysemaChronic Pulmonary Obstructive DiseaseEmphysemaNCT01449175Aeris Therapeutics54
已完成
不适用
Study to Evaluate Safety & Effectiveness of Spinal SealantCerebrospinal Fluid Leakage, SubduralNCT00444067Integra LifeSciences Corporation98
已完成
不适用
ArterX Safety and Efficacy Study for Cardiac IndicationsVascular DiseaseNCT01957904Tenaxis Medical, Inc.44