EUCTR2007-005583-27-IT进行中（未招募）不适用
A multi-center, randomized, prospective, controlled open-label Phase II/III study to assess the safety and sealing efficacy of Kedrion Fibrin Sealant in patients eligible for anatomical pulmonary resection or atypical pulmonary resection. - KB 041 A
KEDRIO0 个研究点开始时间: 2008年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.18 to 75 years old
- •2.Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated
- •3.Patients eligible for anatomical or atypical pulmonary resection
- •lobe resection
- •bilobectomy
- •typical segment resection
- •wedge resection
- •4.Open surgical access (standard thoracotomies, mini-thoracotomies, muscle preserving thoracotomies)
- •5.Life expectancy > six months
- •6.The subjects or their authorized legal representatives must have received adequate information regarding the nature of the trial, agree on study purposes, and have signed an informed consent form approved by the Ethical Committee.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •hypersensitivity to active substances or to any of the excipients and others similar products
- •Parenchymal reseections with the use of thoracoscopy
- •2.Previous ipsilateral thoracotomies
- •3.Patients with lung cancer treated with neo-adjuvants (Chemotherapy or Radiotherapy)
- •4.Patients treated with Pneumonectomy
- •5.Karnofsky Performance Status (KPS) ≤50
- •6.Immunocompromised patients
- •7.Lab test results:
- •Bilirubin >1.5 g/dl
- •Alkaline phosphatase >120 iu/l
- •Blood creatinine > 1.5 mg/dl
- •WBC >10,000/mm3
- •8.Positive pregnancy test
- •9.Presence of any conditions which, in the investigator?s judgment, may interfere with study objective evaluation or with the patient?s participation in the study.
- •10.The patient refused to sign the written informed consent required for participation, or participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days).
研究者
相似试验
已完成
不适用
Post marketing study to evaluate safety and efficacy of suture material (MITSUâ?¢ Polyglactin 910) of Meril Endo Surgery Pvt. Ltd in comparision with coated (Vicrylâ?¢ Polyglactin 910) Suture during surgery for closure of surgical incision.CTRI/2017/01/007717Meril EndoSurgery Pvt Ltd122
进行中（未招募）
不适用
A prospective, multi-center, randomized, controlled, single-blinded study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps. - AdvaCoat Mx sinus gel study for chronic rhinosinusitis without nasal polypsSubjects with chronic rhinosinusitis without nasal polyps, who have not had previous sinus surgery might be eligible for participation in this trial.MedDRA version: 9.1Level: LLTClassification code 10052106Term: RhinosinusitisEUCTR2008-004226-16-NLCarbylan BioSurgery, Inc.100
已完成
不适用
A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.COPD emphysema10038716NL-OMON41236Pulmonx International Sarl25
已完成
不适用
A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema.COPD emphysema10038716NL-OMON43476Pulmonx International Sarl18
进行中（未招募）
不适用
A Prospective, Multi-center, Randomized, Controlled Clinical Investigation of Dermagraft® in Subjects with Venous Leg Ulcers - Dermagraft® in Venous Leg Ulcers (DEVO)Venous leg ulcersMedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)EUCTR2009-010062-33-DEAdvanced BioHealing Inc442