Study of Choroid Plexus Cauderization in Patients With Hydrocephalus

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Brief Title

Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

Official Title

Study of Endoscopic Choroid Plexus Cauterization for Adult Patients With Hydrocephalus and Risk Factors for Perioperative Complications Following Shunt Surgery.

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.
    



Study Type

Interventional


Primary Outcome

Occurrence of post-operative complications

Secondary Outcome

 Shunt independence

Condition

Hydrocephalus

Intervention

endoscopic choroid plexus coagulation

Study Arms / Comparison Groups

 Choroid Plexus Coagulation
Description:  Patients with communicating hydrocephalus will be treated with endoscopic choroid plexus coagulation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1

Start Date

September 1, 2016

Completion Date

May 16, 2018

Primary Completion Date

May 16, 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ronald Benveniste, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02900222

Organization ID

20160650


Responsible Party

Sponsor-Investigator

Study Sponsor

Ronald Benveniste


Study Sponsor

Ronald Benveniste, MD, PhD, Principal Investigator, University of Miami


Verification Date

June 2021