Chronic Pain
Conditions
Keywords
Gemini rechargeable SCS System, ABT-CIP-10407, IPG
Brief summary
The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.
Interventions
DEVICEGemini SCS neuromodulation system
This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, angina pectoris and peripheral vascular disease.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement. 2. Subject is scheduled to receive a new IPG permanent implant and has completed a successful SCS trial in the last 6-months, OR subject is scheduled to undergo an all-in-one procedure OR has an implanted SCS system for an approved chronic pain indication. 3. Subject has a documented NRS pain score of ≥ 6 after at least 5 days without stimulation OR has an implanted functioning SCS system with NRS pain score of ≤ 4. 4. Subject must provide written informed consent prior to any clinical investigation-related procedure. 5. Subject is at least 18 years at the time of enrollment. 6. Subject is capable and willing to recharge an implanted IPG.
Exclusion criteria
1. Subject's SCS trial was unsuccessful. 2. Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott. 3. Subject has or will receive more than one IPG. 4. Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period. 5. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's assessment, could limit the subject's ability to participate in the clinical investigation. 6. Subject has or is scheduled to receive an intrathecal pump. 7. Subject is part of a vulnerable population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System | At 6 weeks (30-45 days) follow-up post implant | The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed. |
Countries
Australia
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Gemini Rechargeable Spinal Cord Stimulation (SCS) System Patients will be implanted with the Gemini rechargeable SCS System | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The patient was indicated for peripheral nerve stimulation | 1 |
Baseline characteristics
| Characteristic | Gemini Rechargeable Spinal Cord Stimulation (SCS) System | — |
|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 15.8 | — |
| Injections or interventions to treat current condition No | 3 Participants | — |
| Injections or interventions to treat current condition Unknown | 1 Participants | — |
| Injections or interventions to treat current condition Yes | 20 Participants | — |
| Manual therapy used to treat current condition No | 3 Participants | — |
| Manual therapy used to treat current condition Yes | 21 Participants | — |
| Primary Indication Back Pain (No Prior Surgery) | 6 Participants | — |
| Primary Indication Failed Back Surgery Syndrome - Fusion | 6 Participants | — |
| Primary Indication Failed Back Surgery Syndrome - Non-Fusion | 3 Participants | — |
| Primary Indication Other | 7 Participants | — |
| Primary Indication Reflex Sympathetic Dystrophy (Complex Regional Pain Syndrome Type I) | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 24 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Time since chronic pain onset | 15.9 years STANDARD_DEVIATION 13.4 | — |
| Type of injection or intervention used Caudal | 5 Participants | — |
| Type of injection or intervention used Epidural steroid injection | 10 Participants | — |
| Type of injection or intervention used Facet joint injection | 11 Participants | — |
| Type of injection or intervention used Intradiscal therapy | 0 Participants | — |
| Type of injection or intervention used Intrathecal Pump | 0 Participants | — |
| Type of injection or intervention used Radiofrequency ablation/rhizotomy | 13 Participants | — |
| Type of injection or intervention used Sacroiliac joint injection | 5 Participants | — |
| Type of injection or intervention used Transforaminal | 7 Participants | — |
| Type of injection or intervention used Translaminar | 0 Participants | — |
| Type of manual therapy used Acupuncture | 1 Participants | — |
| Type of manual therapy used Chiropractic Therapy | 7 Participants | — |
| Type of manual therapy used Massage Therapy | 10 Participants | — |
| Type of manual therapy used Occupational Therapy | 9 Participants | — |
| Type of manual therapy used Physical Therapy | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
Time frame: At 6 weeks (30-45 days) follow-up post implant
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gemini Rechargeable Spinal Cord Stimulation (SCS) System | Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System | 0 Participants |