Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer

NCT01463709 | Completed Phase 1

• 1 other identifier: 2011-049
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)

Conditions

Basal Cell Carcinomas

Keywords

basal cell carcinoma; Basal Cell Nevus Syndrome; Electric Field; Nanosecond pulse

Outcome Measures

Primary Outcomes (1)

• Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.

  1\. Conduct a non-significant risk feasibility clinical trial treating BCCs on the trunk of up to 9 Basal Cell Nevus Syndrome patients with BioElectroMed's PulseCure pulse generator and Derm-Pulse electrode to both demonstrate the safety of nsPEF therapy and identify the optimal pulse number for ablating BCCs.

  One year

Secondary Outcomes (1)

• Determine the efficacy of the PulseCure pulse generator using the optimal pulse number.

  one year

Study Arms (1)

nanopulse

EXPERIMENTAL

Administer nano pulse to lesion for varying time intervals.

Device: PulseCure pulse generator and Derm-pulse electrode

Interventions

PulseCure pulse generator and Derm-pulse electrode DEVICE

PulseCure 100 ns pulse generator: generates 30 kV/cm electric pulses 100 ns long to trigger apoptosis in cells between the electrodes. NanoBlate: Delivery device to treat 5 mm wide skin lesions with 100 ns pulses from PulseCure

Also known as: BioElectroMed

nanopulse

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects must have had diagnosed at least one BCCon their trunk
• The subject is from 18-75 years of age, inclusive.
• The subject must sign and date all informed consent statements.

You may not qualify if:

• The subject is exhibiting signs of a bacterial or viral infection, including fever.
• The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
• The subject has a pace maker or other electronic device implanted

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

Children's Hospital Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Basal Cell Nevus Syndrome

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Ervin E Epstein, MD

  Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 2, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (1)