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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemini rechargeable Spinal Cord Stimulation (SCS) System | Experimental | Patients will be implanted with the Gemini rechargeable SCS System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemini SCS neuromodulation system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 weeks (30-45 days) follow-up post implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPain | Auchenflower | Australia | ||||
| Metro Pain Group |
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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 One subject was withdrawn before IPG implantation without collection of baseline information.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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemini Rechargeable Spinal Cord Stimulation (SCS) System | Patients will be implanted with the Gemini rechargeable SCS System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemini Rechargeable Spinal Cord Stimulation (SCS) System | Patients will be implanted with the Gemini rechargeable SCS System |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | At 6 weeks (30-45 days) follow-up post implant |
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6 weeks after the permanent implant procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemini Rechargeable Spinal Cord Stimulation (SCS) System | Patients will be implanted with the Gemini rechargeable SCS System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devyani Nanduri, Senior Director, Clinical & Regulatory Affairs | Abbott | +16698329450 | devyani.nanduri@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2022 | Aug 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2021 | Aug 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Clayton |
| Australia |
| Sydney Spine & Pain | Hurstville | Australia |
| Sydney Pain Management Centre | Parramatta | Australia |
| Pain Care Perth | Perth | Australia |
| PainMedSA-Pain & Rehabilitation Specialists | Wayville | Australia |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary Indication | Count of Participants | Participants |
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| Time since chronic pain onset | Mean | Standard Deviation | years |
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| Manual therapy used to treat current condition | Count of Participants | Participants |
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| Type of manual therapy used | 21 out of 24 implanted subjects received manual therapy prior to enrollment in the study. | Count of Participants | Participants |
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| Injections or interventions to treat current condition | Count of Participants | Participants |
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| Type of injection or intervention used | 20 out of 24 implanted subjects received injection or intervention prior to enrollment in the study | Count of Participants | Participants |
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| Participants |
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| 0 |
| 24 |
| 0 |
| 24 |
| 1 |
| 24 |
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.