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Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

R

Ronald Benveniste

Status

Terminated

Conditions

Hydrocephalus

Treatments

Procedure: endoscopic choroid plexus coagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02900222
20160650

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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