We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"
Previous Study | Return to List | Next Study

Study of Choroid Plexus Cauderization 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02900222
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Hydrocephalus Procedure: endoscopic choroid plexus coagulation

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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.
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Contacts and Locations

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


Contacts
Contact: Ronald Benveniste, MD, PhD 305-575-7059 rbenveniste@med.miami.edu
Contact: Sarah Jernigan, MD 305-585-4323 sxj208@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ronald Benveniste, MD, PhD    305-575-7059    rbenveniste@med.miami.edu   
Sponsors and Collaborators
Ronald Benveniste
More Information

Responsible Party: Ronald Benveniste, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02900222     History of Changes
Other Study ID Numbers: 20160650
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases