Spots Global Cancer Trial Database for Bioseal Dural Sealing Study BIOS-14-001
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Trial Identification
Brief Title: Bioseal Dural Sealing Study BIOS-14-001
Official Title: A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair
Study ID: NCT03110783
Interventions
Study Description
Brief Summary: A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair
Detailed Description: This is a randomized, single blinded, multi-center controlled study evaluating the effectiveness of Bioseal as an adjunct to sutured dural closure compared to control to obtain an intra-operative watertight dural closure.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Xuanwu Hospital Capital Medical University, Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
ZhuJiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
The first Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
TongJi Hospital, TongJi Medical College of HUST, Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, Shanghai, China
Contact Details
Name: Ying Mao, MD, PhD
Affiliation: Hua Shan Hospital, Shanghai Medical College, Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Kocharian, MD, PhD
Affiliation: Ethicon, Inc.
Role: STUDY_DIRECTOR
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