Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

NCT02900222 | Terminated

• 1 other identifier: 20160650
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Occurrence of post-operative complications

  Complications will be defined as new neurologic deficits after surgery; hemorrhage or stroke on postoperative imaging studies; or other perioperative complications.

  30 days

Secondary Outcomes (1)

• Shunt independence

  1 year

Study Arms (1)

Choroid Plexus Coagulation

EXPERIMENTAL

Patients with communicating hydrocephalus will be treated with endoscopic choroid plexus coagulation.

Procedure: endoscopic choroid plexus coagulation

Interventions

endoscopic choroid plexus coagulation PROCEDURE

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.

Choroid Plexus Coagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ronald Benveniste: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ronald Benveniste, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)