Study of Choroid Plexus Cauderization in Patients With Hydrocephalus
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|ClinicalTrials.gov Identifier: NCT02900222|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus||Procedure: endoscopic choroid plexus coagulation||Not Applicable|
The patient will undergo endoscopic choroid plexus coagulation surgery to treat communicating hydrocephalus. Before the surgery, the patient will be examined by his/her doctors and undergo brain MRI, as part of routine clinical care. For the surgery, he/she will be placed under general anesthesia. An incision will be made on the top of the head, and a small opening made in the bone of the skull. An endoscope, which is a long, thin metal tube with an attached video camera and channels for passing small instruments, will be passed into the ventricles of the brain through the opening. After the surgeon identifies the choroid plexus on one side of the brain using the endoscope, an electrical current will be used to destroy as much of the choroid plexus on that side as possible. A balloon or other instrument will be used to open the membrane that separates the right and left halves of the brain. The endoscope will then be used to identify the choroid plexus on the opposite side of the brain, and the electrical current will be used to destroy as much of the choroid plexus on that side, as possible. The ventricles of the brain will be washed with a saline solution to remove blood and debris, and the endoscope will be removed from the brain. A temporary drainage tube may be left in place to monitor fluid pressures after surgery. The openings in the skull and scalp will be closed. The patient will be awakened from anesthesia and brought to either the recovery room or intensive care unit. The patient will be observed in the hospital for at least one night, and will undergo MRI of the brain after surgery as part of routine clinical care.
The patient will have follow up visits after surgery, as part of routine clinical care. During hospitalization for the procedure, and during follow up clinic visits, the treating doctors will examine and interview the patient as part of routine clinical care. The researchers will collect information from these examinations, interviews, and, when appropriate, brain imaging studies in order to determine whether the surgery caused any complications, and whether it prevented the patient from requiring a ventricular shunt.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Endoscopic Choroid Plexus Cauterization for Adult Patients With Hydrocephalus and Risk Factors for Perioperative Complications Following Shunt Surgery.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Choroid Plexus Coagulation
Patients with communicating hydrocephalus will be treated with endoscopic choroid plexus coagulation.
Procedure: endoscopic choroid plexus coagulation
A burr hole will be made over the frontal lobe of the brain. An endoscope will be introduced into the ventricle of the brain and the choroid plexus coagulated with an electrocautery device. The septum pellucidum separating the right and left lateral ventricles will be opened, and the choroid plexus on the opposite side coagulated as well.
- Occurrence of post-operative complications [ Time Frame: 30 days ]Complications will be defined as new neurologic deficits after surgery; hemorrhage or stroke on postoperative imaging studies; or other perioperative complications.
- Shunt independence [ Time Frame: 1 year ]Shunt independence is defined as the patient surviving with no need for ventricular shunt placement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900222
|Contact: Ronald Benveniste, MD, PhDfirstname.lastname@example.org|
|Contact: Sarah Jernigan, MDemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ronald Benveniste, MD, PhD 305-575-7059 firstname.lastname@example.org|