Trial Outcomes & Findings for Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System (NCT NCT05590000)
NCT ID: NCT05590000
Last Updated: 2023-10-24
Results Overview
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
At 6 weeks (30-45 days) follow-up post implant
Results posted on
2023-10-24
Participant Flow
The study enrolled a total of 25 subjects at six investigational sites in Australia. The pre-market study enrolled the first subject on 20 September 2022 and the last subject on 09 December 2022. Completion of follow-up in the pre-market study occurred on 19 January 2023. One subject was withdrawn before IPG implantation without collection of baseline information. All other subjects were implanted and completed 2-week and 6-week visits.
Participant milestones
| Measure |
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Patients will be implanted with the Gemini rechargeable SCS System.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Patients will be implanted with the Gemini rechargeable SCS System.
|
|---|---|
|
Overall Study
The patient was indicated for peripheral nerve stimulation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
n=24 Participants
Patients will be implanted with the Gemini rechargeable SCS System
|
|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 15.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
24 participants
n=24 Participants
|
|
Primary Indication
Back Pain (No Prior Surgery)
|
6 Participants
n=24 Participants
|
|
Primary Indication
Failed Back Surgery Syndrome - Fusion
|
6 Participants
n=24 Participants
|
|
Primary Indication
Failed Back Surgery Syndrome - Non-Fusion
|
3 Participants
n=24 Participants
|
|
Primary Indication
Reflex Sympathetic Dystrophy (Complex Regional Pain Syndrome Type I)
|
2 Participants
n=24 Participants
|
|
Primary Indication
Other
|
7 Participants
n=24 Participants
|
|
Time since chronic pain onset
|
15.9 years
STANDARD_DEVIATION 13.4 • n=24 Participants
|
|
Manual therapy used to treat current condition
Yes
|
21 Participants
n=24 Participants
|
|
Manual therapy used to treat current condition
No
|
3 Participants
n=24 Participants
|
|
Type of manual therapy used
Physical Therapy
|
21 Participants
n=21 Participants • 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study.
|
|
Type of manual therapy used
Occupational Therapy
|
9 Participants
n=21 Participants • 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study.
|
|
Type of manual therapy used
Massage Therapy
|
10 Participants
n=21 Participants • 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study.
|
|
Type of manual therapy used
Chiropractic Therapy
|
7 Participants
n=21 Participants • 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study.
|
|
Type of manual therapy used
Acupuncture
|
1 Participants
n=21 Participants • 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study.
|
|
Injections or interventions to treat current condition
Yes
|
20 Participants
n=24 Participants
|
|
Injections or interventions to treat current condition
No
|
3 Participants
n=24 Participants
|
|
Injections or interventions to treat current condition
Unknown
|
1 Participants
n=24 Participants
|
|
Type of injection or intervention used
Epidural steroid injection
|
10 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Transforaminal
|
7 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Translaminar
|
0 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Caudal
|
5 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Facet joint injection
|
11 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Sacroiliac joint injection
|
5 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Radiofrequency ablation/rhizotomy
|
13 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Intradiscal therapy
|
0 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
|
Type of injection or intervention used
Intrathecal Pump
|
0 Participants
n=20 Participants • 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study
|
PRIMARY outcome
Timeframe: At 6 weeks (30-45 days) follow-up post implantPopulation: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
Outcome measures
| Measure |
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
n=24 Participants
Patients will be implanted with the Gemini rechargeable SCS System
|
|---|---|
|
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
|
0 Participants
|
Adverse Events
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
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 |
Gemini Rechargeable Spinal Cord Stimulation (SCS) System
n=24 participants at risk
Patients will be implanted with the Gemini rechargeable SCS System
|
|---|---|
|
Nervous system disorders
CEREBROSPINAL FLUID LEAKAGE
|
4.2%
1/24 • 6 weeks after the permanent implant procedure
|
Additional Information
Devyani Nanduri, Senior Director, Clinical & Regulatory Affairs
Abbott
Phone: +16698329450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish the study results until publication of the results of the multi-center study or 2 years after study completion, whichever is sooner and allows the Sponsor to review any proposed publication at least 40 days before forwarding it to any person that is not bound by the confidentiality agreement between Sponsor and PI.
- Publication restrictions are in place
Restriction type: OTHER