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A multi-center clinical trial to evaluate the safety and efficacy of MRI-guided laser ablation system for epilepsy

A multi-center clinical trial to evaluate the safety and efficacy of MRI-guided laser ablation system for epilepsy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038322
Enrollment
Unknown
Registered
2020-09-17
Start date
2020-08-08
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Epilepsy

Interventions

Trial group:LITT treatment

Sponsors

Beijing Tiantan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 6 months to 70 years old; 2. Patients who were previously diagnosed with drug-resistant epilepsy and focal seizures; 3. Patients with average seizure frequency >= 2 times / month 3 months before screening; 4. Patients with limited epileptogenic focus and suitable for surgical treatment; 5. The subjects or their guardians can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. MRI contraindication patients; 2. Patients with severe coagulation dysfunction; 3. Pregnant or lactating women; 4. Subjects who have participated in clinical trials of any other drugs or medical devices within 3 months before screening; 5. Patients with evidence of serious or uncontrollable systemic diseases as judged by researchers; 6. Subjects considered unsuitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
MRI-guided LITT ablation rate;

Secondary

MeasureTime frame
Seizure free rate;Seizure reduction rate;Surgical time;Postsurgical time;MMSE score;QOLIE-31, QOLIE-AD-48 scores;Instrument performance evaluation;

Countries

China

Contacts

Public ContactKai Zhang

Beijing Tiantan Hospital Affiliated to Capital Medical University

zhangkai62035@sina.com+86 13501196619

Outcome results

None listed

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