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A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial Of SonoCloud-9 Combined With Carboplatin (CBDCA) Vs Standard Of Care Lomustine (CCNU) Or Temozolomide (TMZ) In Patients Undergoing Planned Resection For First Recurrence Glioblastoma. (SONOBIRD)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
Closed for Enrollment
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A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
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ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH). (ENRICH)
Jacksonville, Fla.
The purpose of this study is to provide clinical evidence of functional improvement, safety, and economic benefit when comparing intracerebral hemorrhage (ICH) evacuation surgery to medical treatment.
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Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Jacksonville, Fla.
The purpose of this study is to compare local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
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Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery - ENCASE II (ENCASE II)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra-, as well as post-operative, CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.
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Use of Handheld Dynamometer as a Novel Tool to Assess Motor Function During Awake Craniotomy for Gliomas Located Within or Adjacent to the Motor Cortex: A Single-Center Pilot Study
Jacksonville, Fla.
The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of glioma located within or adjacent to the motor cortex.
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