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Study Involving Identification of Cerebrospinal Fluid Biomarker and Developing a Bedside Testing Device for rapid and accurate Diagnosis Cerebrospinal Fluid leak in Suspected Individuals

Identification and Validation of Cerebrospinal fluid (CSF) Biomarker in Bodily fluids and Development of Point of Care Device for Diagnosing CSF leak - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/080571
Enrollment
255
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G960- Cerebrospinal fluid leak

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Saraswathi N
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients above the age of 18 years 2. Patients suspicious of CSF leak with clinical symptoms such as orthostatic headache or recurrent rhinorrhea or otorrhea after trauma or endonasal surgery or spontaneously.

Exclusion criteria

Exclusion criteria: 1. Pregnant women. 2. Patient with a history of neurological disorders. 3. Patients undergoing treatment for neurological disorders.

Design outcomes

Primary

MeasureTime frame
To measure specificity, sensitivity and diagnostic accuracy of identified biomarker and developed assay method in diagnosing CSF leakTimepoint: 3 years 6 months—

Secondary

MeasureTime frame
To identify more sensitive and specific biomarker for CSF leak diagnosisTimepoint: 1 year;Evaluation of clinical performance of the POC device developed for diagnosing CSF leakTimepoint: 18 months—

Countries

India

Contacts

Public ContactDrSuresh Pillai

Kasturba Medical College, Manipal

revathi.shenoy@manipal.edu9449367734

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026