ASIS for GAMMAGARD in Primary Immunodeficiency

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ASIS Corporation
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Inclusion Criteria in general and for Gadolinium:

• Main Criteria for Inclusion: Eligible Ages: 12 Years to 65

• Genders Eligible for Study: Both

• Accepts Healthy Volunteers: Yes

• Must be outpatient, male or female, of any race, between 18 and 65 years of age.

• Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.

• Must be in good general health as determined by investigator.

• If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception

• Inclusion Criteria for Primary Immunodeficiency in particular:

• Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.

Exclusion Criteria:

• Exclusion Criteria for Primary Immunodeficiency in particular:

• Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.