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Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

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ClinicalTrials.gov Identifier: NCT02900222
Recruitment Status : Terminated (Resources no longer available)
First Posted : September 14, 2016
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Ronald Benveniste, University of Miami

Brief Summary:
The purpose of this study is to determine whether endoscopic choroid plexus coagulation is safe in adult patients with communicating hydrocephalus and risk factors for complications from the standard surgical treatment. It may also help determine whether the endoscopic choroid plexus coagulation is effective in treating your communicating hydrocephalus. The Investigators hope that this research will allow us to place fewer shunts in patients with conditions similar to yours, avoiding complications.

Condition or disease Intervention/treatment Phase
Hydrocephalus Procedure: endoscopic choroid plexus coagulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Shunt independence [ Time Frame: 1 year ]
    Shunt independence is defined as the patient surviving with no need for ventricular shunt placement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age 18 or older) with communicating hydrocephalus, who have risk factors for complications following shunt surgery. Risk factors include loculated hydrocephalus (i.e., imaging evidence that the ventricles of the brain do not communicate with each other, in the setting of known communicating hydrocephalus); prior episodes of ventriculitis and/or shunt infection; subdural hematoma associated with shunt placement; inability to place a distal catheter in the peritoneal cavity due to scarring or prior infection; and multiple prior episodes of shunt failure.
  • In patients with communicating hydrocephalus who have significantly increased lateral and third ventricular size and normal fourth ventricular size, an endoscopic third ventriculostomy will be performed in conjunction with the choroid plexus cauterization, provided that communicating hydrocephalus is thought to be present, based on either the history (for example, past meningitis or other infectious or inflammatory disease, or history of communicating hydrocephalus without disproportion of the ventricles in the past; or imaging findings, such as patency of the foramina of Magendie and Luschka).

Exclusion Criteria:

  • Exclusion criteria include patients who have non-communicating hydrocephalus; patients who are undergoing emergency surgery because of rapid decline in neurologic condition; and patients with medical conditions such as coagulopathy or severe cardiac conditions, that preclude neurosurgical intervention.
  • In the case of adults unable to consent, informed consent will be obtained from appointed health care proxies. Minors, pregnant women, and prisoners will be excluded from the study.

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Ronald Benveniste
Investigators
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Principal Investigator: Ronald Benveniste, MD, PhD University of Miami
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Responsible Party: Ronald Benveniste, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02900222    
Other Study ID Numbers: 20160650
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases