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A preclinical trial to evaluate the safety and efficacy of the pulse ablation system and disposable pulse ablation electrodes in the treatment of oral potential malignant diseases

A preclinical trial to evaluate the safety and efficacy of the pulse ablation system and disposable pulse ablation electrodes in the treatment of oral potential malignant diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095789
Enrollment
Unknown
Registered
2025-01-13
Start date
2024-08-22
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Oral potential malignant diseases (oral leukoplakia, erosive ulcerative lichen planus, erythema, chronic discoid lupus erythematosus, etc.)

Interventions

Lesion group:Pulse ablation surgery

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) 18 years old = age = 70 years old; 2) Patients diagnosed with oral potential malignant diseases (i.e. oral leukoplakia, erosive ulcerative lichen planus, etc.); 3) Bilateral lesions are distributed in relatively flat areas such as cheeks and tongue and are clearly visible; 4) Patients who voluntarily participate and sign the informed consent form and can cooperate to complete the entire trial process.

Exclusion criteria

Exclusion criteria: 1) Patients with severe epithelial dysplasia; 2) Carcinoma in situ or invasive cancer as shown by biopsy; 3) Active infection or open wound in the treatment area; 4) Untreated arrhythmia within two years; 5) Implanted cardiac pacemaker and/or other active implants; 6) Severe coagulation disorder or obvious bleeding tendency (platelet 1.5 times the upper limit of normal value); 7) Patients with contraindications to local anesthesia as assessed by the investigator; 8) Eating irritating food such as alcohol after surgery; 9) Patients with scar constitution; 10) Severe functional failure of major organs (heart, liver, kidney) (heart function grade =III; 1.ALT, AST >1.5 times the upper limit of normal value; 2.serum creatinine >1.5 times the upper limit of normal value); 11) Life expectancy less than 12 months; 12) Psychiatric patients who cannot cooperate with treatment; 13) Patients with other serious systemic diseases; 14) The patient is pregnant, breastfeeding or planning to become pregnant during the study; 15) The patient is currently participating in another clinical study involving the research product; 16) The researcher believes that there are other circumstances that make the patient unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Clinical Effectiveness;

Countries

China

Contacts

Public ContactLu Jiang

West China Hospital of Stomatology, Sichuan University

jianglu@scu.edu.cn+86 28 8550 3480

Outcome results

None listed

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