An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer
Electroporation therapy (EPT) is a tumor-specific ablative treatment modality with the
potential to manage local tumors without the potentially undesirable side effects of
systemic chemotherapy agents or radiotherapy. Surgical resection of cutaneous lesions may
lead to significant organ dysfunction and/or permanent disfigurement requiring
reconstructive surgery (i.e. nose, eye area, ears, medial canthus, nasolabial fold, lip,
scalp, etc.). In contrast, electroporation therapy may offer equivalent disease control to
conventional surgery with a lessened need for reconstructive surgery.
The ability to ablate local cutaneous lesions with the MedPulser® System when used in
conjunction with intralesional Bleomycin is an important new treatment for the local
management of recurrent Basal Cell Carcinoma (BCC), recurrent Squamous Cell Carcinoma (SCC),
Melanoma, Adenocarcinoma (i.e. local recurrence of breast cancer), Merkel Cell Carcinoma and
Cutaneous Lymphoma and other solid tumors with symptomatic subcutaneous recurrences and
provides an alternative treatment option to subjects who:
1. have failed standard treatments; or who
2. are unwilling or unsuitable to undergo conventional surgical excision or radiation.
EPT with Bleomycin spares normal tissue and its use in local disease management may preserve
organ function and/or appearance relative to surgery.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local tumor control
Paul Goldfarb, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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