NCT04569071

Brief Summary

Multicenter, open-label, prospective designed study to characterize the performance of MRI-guided laser interstitial thermal therapy (MgLiTT) using the Sinovation Laser Ablation System for the treatment of medical refractory epilepsy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 10, 2020

Last Update Submit

September 23, 2020

Conditions

Epilepsy

Keywords

Stereotactic surgeryThermal ablationMedical refractory epilepsyEpilepsy surgery

Outcome Measures

Primary Outcomes (1)

  • MgLiTT ablation rate

    Measurement of postsurgical MRI

    Within 3 days after operation

Secondary Outcomes (11)

  • Seizure free rate

    90±7 days after operation

  • Seizure reduction rate

    90±7 days after operation

  • Operation time

    Within 1 day after operation

  • Postsurgical hospitalization

    Within 1 day after discharged from hospital

  • Mini-Mental State Examination (MMSE) score

    Before and 90±7 days after operation

  • +6 more secondary outcomes

Other Outcomes (6)

  • Instrument performance evaluation

    Within 1 day after operation

  • The amount of bleeding

    During operation

  • Postsurgical complication rates

    Within 1 day after discharged from hospital

  • +3 more other outcomes

Study Arms (1)

Sinovation Laser Ablation System treatment

EXPERIMENTAL

Sinovation Laser Ablation System treatment

Device: Sinovation Laser Ablation System

Interventions

Sinovation Laser Ablation SystemDEVICE

In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

Sinovation Laser Ablation System treatment

Eligibility Criteria

Age6 Months - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The age ranged from 6 months to 70 years old;
  • Previous diagnosis of drug-resistant epilepsy with focal lesions;
  • The average seizure frequency was more than 2 times/month within 3 months;
  • Surgical treatment is suitable for epilepsy;
  • 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.

You may not qualify if:

  • MRI contraindication;
  • Patients with severe coagulation dysfunction;
  • Pregnant or lactating women;
  • Subjects who have participated in clinical trials of any other drugs or medical devices within 3 months;
  • Evidence of severe or uncontrollable systemic diseases, as judged by the researchers;
  • Subjects considered unsuitable for the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kai Zhang, Dr.

    Beijing Tiantan Hospital

    STUDY DIRECTOR

Central Study Contacts

Kai Zhang, Dr.

CONTACT

+86 13501196619zhangkai62035@sina.com

Xiu Wang, Dr.

CONTACT

+86 13520908011wang19001@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 29, 2020

Study Start

August 8, 2020

Primary Completion

May 8, 2021

Study Completion

February 8, 2022

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

We may only share clinical information (rather privacy information) in academic or other reasonable request.

Shared Documents
ANALYTIC CODE
Time Frame
After the clinical trials.
Access Criteria
reasonable requests.

Locations

CN(1)