60
Participants
Start Date
January 31, 2016
Primary Completion Date
June 30, 2016
Study Completion Date
June 30, 2016
Gadolinium For abdomen
"Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.~Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs."
Gadolinium For abdomen
"Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.~Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs."
Gadolinium For abdomen
Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
Gadolinium For lower back
Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.
Gadolinium For lower back
Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.
Gadolinium For lower back
Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
Efficacy of Gammagard subcutaneously at Week 12
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 12
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
Efficacy of Gammagard subcutaneously at Week 24
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
Efficacy of Gammagard subcutaneously at Week 24
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 24
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
Efficacy of Gammagard subcutaneously at Week 36
subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36
Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36
subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36
Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subcutaneously at Week 36
subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36
(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
Efficacy of Gammagard subdermally at Week 12
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
Efficacy of Gammagard subdermally at Week 12
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
Efficacy of Gammagard subdermally at Week 24
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 24
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
Efficacy of Gammagard subdermally at Week 36
subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Efficacy of Gammagard subdermally at Week 36
Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
Adverse Reactions of Gammagard subcutaneously at Week 12
Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 24
Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subcutaneously at Week 36
Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 12
Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
Adverse Reactions of Gammagard subdermally at Week 24
Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Adverse Reactions of Gammagard subdermally at Week 36
Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
Automatic Subdermal Injector System, Inc, Westminster
Lead Sponsor
ASIS Corporation
INDUSTRY