ASIS for GAMMAGARD in Primary Immunodeficiency

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Primary Immunodeficiency

In brief

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."

Key facts

Study ID

NCT02123615

Run by

ASIS Corporation

People needed

60

Starts

2016-01-01

Expected to finish

2016-06-01

Last updated by the study team

2015-06-24

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Automatic Subdermal Injector System, Inc — Westminster, California, United States

Full record on ClinicalTrials.gov

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