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NCT05198882: EPILITT
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
Phase 1 trial testing Laser technology for intracerebral thermocoagulation in Drug-resistant Focal Epilepsy in 13 participants. Status unknown.
15 September 2023
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 4 July 2022 |
| Primary completion | 15 September 2023 |
| Estimated completion | 15 August 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Laser technology for intracerebral thermocoagulation
Conditions studied
- Drug-resistant Focal Epilepsy — all drugs for Drug-resistant Focal Epilepsy →
- Epilepsy — all drugs for Epilepsy →
- Epilepsies, Focal — all drugs for Epilepsies, Focal →
- Focal Epilepsy — all drugs for Focal Epilepsy →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 80, any sex, with Drug-resistant Focal Epilepsy or Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05198882
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05198882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 4 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05198882.
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