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ASIS for GAMMAGARD in Primary Immunodeficiency (ASISinPI)
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."
Details
| Lead sponsor | ASIS Corporation |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2016-01 |
| Completion | 2016-06 |
Conditions
- Primary Immunodeficiency
Interventions
- Gadolinium For abdomen
- Gadolinium For abdomen
- Gadolinium For abdomen
- Gadolinium For lower back
- Gadolinium For lower back
- Gadolinium For lower back
- Efficacy of Gammagard subcutaneously at Week 12
- Efficacy of Gammagard subcutaneously at Week 12
- Efficacy of Gammagard subcutaneously at Week 12
- Efficacy of Gammagard subcutaneously at Week 12
Primary outcomes
- Relative Prolongation Ability Score for Gadolinium subdermally injected — 6 months
Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Primary Immunodeficiency. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, in Primary Immunodeficiency will be very valuable indicators for us to modify the GAMMAGARD dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.
Countries
United States