Study of Choroid Plexus Cauterization in Patients With Hydrocephalus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02900222|
Recruitment Status : Terminated (Resources no longer available)
First Posted : September 14, 2016
Last Update Posted : June 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus||Procedure: endoscopic choroid plexus coagulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 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.|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||May 16, 2018|
|Actual Study Completion Date :||May 16, 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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Ronald Benveniste, MD, PhD||University of Miami|