Trial Outcomes & Findings for Evaluation of the Performance and Safety of Two Intradermal Delivery Devices. (NCT NCT01943110)
NCT ID: NCT01943110
Last Updated: 2016-03-02
Results Overview
The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
1 day
Results posted on
2016-03-02
Participant Flow
Participant milestones
| Measure |
Saline Injection With ID Adapters
Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
* Upper deltoid with the side-load ID adapter
* Upper deltoid with the AD ID adapter
* Suprascapular (behind the shoulder) with the side-load ID adapter
* Suprascapular with the AD ID adapter
* Forearm with the side-load ID adapter
* Forearm with the AD ID adapter
ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
Baseline characteristics by cohort
| Measure |
Saline Injection With ID Adapters
n=30 Participants
Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
* Upper deltoid with the side-load ID adapter
* Upper deltoid with the AD ID adapter
* Suprascapular (behind the shoulder) with the side-load ID adapter
* Suprascapular with the AD ID adapter
* Forearm with the side-load ID adapter
* Forearm with the AD ID adapter
ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.
Outcome measures
| Measure |
ADID Deltoid
n=29 Injections
Injections given with the autodisable ID adapter in the deltoid region
|
ADID Forearm
n=30 Injections
Injections given with the autodisable ID adapter in the forearm
|
ADID Suprascapular
n=30 Injections
Injections given with the autodisable ID adapter in the suprascapular region
|
SLA Deltoid
n=30 Injections
Injections given with the side-load ID adapter in the deltoid region
|
SLA Forearm
n=30 Injections
Injections given with the side-load ID adapter in the forearm
|
SLA Suprascapular
n=30 Injections
Injections given with the side-load ID adapter in the suprascapular region
|
|---|---|---|---|---|---|---|
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Proportion of Injections Delivered to the Intradermal Layer of the Skin
Wheal diameter >=5mm
|
28 Injections
|
30 Injections
|
30 Injections
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30 Injections
|
30 Injections
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30 Injections
|
|
Proportion of Injections Delivered to the Intradermal Layer of the Skin
Leakage <=10%
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28 Injections
|
30 Injections
|
29 Injections
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30 Injections
|
30 Injections
|
30 Injections
|
SECONDARY outcome
Timeframe: Within 30 minutes and within 48 hours of injectionThe proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.
Outcome measures
| Measure |
ADID Deltoid
n=89 Injections
Injections given with the autodisable ID adapter in the deltoid region
|
ADID Forearm
n=90 Injections
Injections given with the autodisable ID adapter in the forearm
|
ADID Suprascapular
Injections given with the autodisable ID adapter in the suprascapular region
|
SLA Deltoid
Injections given with the side-load ID adapter in the deltoid region
|
SLA Forearm
Injections given with the side-load ID adapter in the forearm
|
SLA Suprascapular
Injections given with the side-load ID adapter in the suprascapular region
|
|---|---|---|---|---|---|---|
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Proportion of Injections With Safety Events
Local AE at 30 minutes post-injection
|
5.6 percentage of injections
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4.4 percentage of injections
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—
|
—
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—
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—
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|
Proportion of Injections With Safety Events
Local AE at 2 days post-injection
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0 percentage of injections
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0 percentage of injections
|
—
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—
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—
|
—
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Adverse Events
ADID Deltoid
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ADID Forearm
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ADID Suprascapular
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SLA Deltoid
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SLA Forearm
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SLA Suprascapular
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADID Deltoid
n=30 participants at risk
Injections given with the autodisable ID adapter in the deltoid region
|
ADID Forearm
n=30 participants at risk
Injections given with the autodisable ID adapter in the forearm region
|
ADID Suprascapular
n=30 participants at risk
Injections given with the autodisable ID adapter in the suprascapular region
|
SLA Deltoid
n=30 participants at risk
Injections given with the side-load ID adapter in the deltoid region
|
SLA Forearm
n=30 participants at risk
Injections given with the side-load ID adapter in the forearm region
|
SLA Suprascapular
n=30 participants at risk
Injections given with the side-load ID adapter in the suprascapular region
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|---|---|---|---|---|---|---|
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Skin and subcutaneous tissue disorders
Local AE at injection site 30 minutes after injection
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3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
13.3%
4/30 • Number of events 4 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
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0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
6.7%
2/30 • Number of events 2 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
|
Skin and subcutaneous tissue disorders
Abrasion at injection site immediately after injection
|
3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
6.7%
2/30 • Number of events 2 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
6.7%
2/30 • Number of events 2 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
3.3%
1/30 • Number of events 1 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
|
Skin and subcutaneous tissue disorders
Drop of blood at injection site immediately after injection
|
33.3%
10/30 • Number of events 10 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
30.0%
9/30 • Number of events 9 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
33.3%
10/30 • Number of events 10 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
26.7%
8/30 • Number of events 8 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
43.3%
13/30 • Number of events 13 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
36.7%
11/30 • Number of events 11 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
|
General disorders
Systemic AE
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
|
Skin and subcutaneous tissue disorders
Local AEs at injection site 2 days after injection
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
0.00%
0/30 • 2 days
Certain signs and symptoms were pre-specified in the case report form for participants in the study. These included bleeding, redness, pain, bruising, and abrasion at the injection site. There was also space for recording other local or systemic AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor, funder, and PI of this study have jointly published the results.
- Publication restrictions are in place
Restriction type: OTHER