Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study to Evaluate Safety & Effectiveness of Spinal Sealant
This study is currently recruiting participants.
Verified by Confluent Surgical, April 2008
Sponsored by: Confluent Surgical
Information provided by: Confluent Surgical
ClinicalTrials.gov Identifier: NCT00444067
  Purpose

To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.


Condition Intervention Phase
Cerebrospinal Fluid Leakage, Subdural
Device: Spinal Sealant
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Further study details as provided by Confluent Surgical:

Study Start Date: March 2007
Detailed Description:

Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nause and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Subjects scheduled for a spinal procedure that requires a dural incision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444067

Contacts
Contact: Vladimir I Scerbin (781) 693-2305

Locations
United States, Massachusetts
Confluent Surgical, Inc. Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Vladimir I Scerbin     781-693-2305        
Sponsors and Collaborators
Confluent Surgical
Investigators
Study Director: Vladimir I Scerbin Conlfuent Surgical
  More Information

Study ID Numbers: DS3-06-002
Study First Received: March 6, 2007
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00444067  
Health Authority: United States: Food and Drug Administration

Keywords provided by Confluent Surgical:
Prevention of CSF leak

Study placed in the following topic categories:
Hypotension
Craniocerebral Trauma
Cerebrospinal Fluid Rhinorrhea
Cerebrospinal fluid leak
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Signs and Symptoms
Central Nervous System Infections
Neurologic Manifestations
Subdural Effusion
Intracranial Hypotension

Additional relevant MeSH terms:
Nervous System Diseases
Perimeningeal Infections

ClinicalTrials.gov processed this record on January 16, 2009