Trial Outcomes & Findings for Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode (NCT NCT04672096)
NCT ID: NCT04672096
Last Updated: 2024-04-19
Results Overview
Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
28 days
Results posted on
2024-04-19
Participant Flow
Participant milestones
| Measure |
Neuronoff BASMATI Injectrode
This group was evaluated to 1) assess tissue responses and, on the last day just prior to explant, 2) collect data describing the quality of the electrical interfacing with the Injectrode from outside of the body, as well as with subcutaneous sensory nerves surrounding the Injectrode insert.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neuronoff BASMATI Injectrode
n=10 Participants
See Inclusion/Exclusion Criteria
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=10 Participants
|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPrimary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
Outcome measures
| Measure |
Neuronoff BASMATI Injectrode
n=10 Participants
Subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days. On the day of explant, stimulation of the Injectrode will occur for approximately 30 minutes.
Neuronoff BASMATI Injectrode: The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.
|
|---|---|
|
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
|
0 Participants
|
Adverse Events
Neuronoff BASMATI Injectrode
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neuronoff BASMATI Injectrode
n=10 participants at risk
Subjects will be provided with the placement of an Injectrode insert. The maximal placement duration will be 28 days.
Neuronoff BASMATI Injectrode: The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Shingles - Unrelated
|
10.0%
1/10 • Number of events 1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place