ASIS for GAMMAGARD in Primary Immunodeficiency
Public ClinicalTrials.gov record NCT02123615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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."
Study identification
- NCT ID
- NCT02123615
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Gadolinium For abdomen Drug
- Gadolinium For lower back Drug
- Efficacy of Gammagard subcutaneously at Week 12 Drug
- Efficacy of Gammagard subcutaneously at Week 24 Drug
- Efficacy of Gammagard subcutaneously at Week 36 Drug
- Efficacy of Gammagard subdermally at Week 36 Drug
- Efficacy of Gammagard subdermally at Week 12 Drug
- Efficacy of Gammagard subdermally at Week 24 Drug
- Adverse Reactions of Gammagard subcutaneously at Week 12 Drug
- Adverse Reactions of Gammagard subcutaneously at Week 24 Drug
- Adverse Reactions of Gammagard subcutaneously at Week 36 Drug
- Adverse Reactions of Gammagard subdermally at Week 12 Drug
- Adverse Reactions of Gammagard subdermally at Week 24 Drug
- Adverse Reactions of Gammagard subdermally at Week 36 Drug
Drug
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2015
- Primary completion
- May 31, 2016
- Completion
- May 31, 2016
- Last update posted
- Jun 23, 2015
2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Automatic Subdermal Injector System, Inc | Westminster | California | 92683 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02123615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02123615 live on ClinicalTrials.gov.