Trial Outcomes & Findings for Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector (NCT NCT01643213)
NCT ID: NCT01643213
Last Updated: 2020-11-13
Results Overview
Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
30 minutes after activation of stimulation
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Treatment to Control
Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
|
Control to Treatment
Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector
Baseline characteristics by cohort
| Measure |
Treatment to Control
n=13 Participants
Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
|
Control to Treatment
n=14 Participants
Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
56 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment: United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after activation of stimulationSubject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline
Outcome measures
| Measure |
Treatment to Control
n=12 Participants
Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
|
Control to Treatment
n=13 Participants
Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
|
|---|---|---|
|
Subject's Treatment Preference
Period 1 Yes, Period 2 Yes
|
6 participants
|
3 participants
|
|
Subject's Treatment Preference
Period 1 Yes, Period 2 No
|
1 participants
|
2 participants
|
|
Subject's Treatment Preference
Period 1 No, Period 2 Yes
|
1 participants
|
4 participants
|
|
Subject's Treatment Preference
Period 1 No, Period 2 No
|
4 participants
|
4 participants
|
Adverse Events
Treatment to Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control to Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place