Chronic PainNCT05590000
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
A study testing Gemini SCS neuromodulation system in people with Chronic Pain, run by Abbott Medical Devices at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Gemini SCS neuromodulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesAustralia
- Study dates
- 20 Sep 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement.
- 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.
- 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.
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years at the time of enrollment.
- Subject is capable and willing to recharge an implanted IPG.
Who cannot join
- Subject's SCS trial was unsuccessful.
- Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott.
- Subject has or will receive more than one IPG.
- Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period.
- 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.
- Subject has or is scheduled to receive an intrathecal pump.
- Subject is part of a vulnerable population.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
QPain
Auchenflower
Metro Pain Group
Clayton
Sydney Spine & Pain
Hurstville
Sydney Pain Management Centre
Parramatta
Pain Care Perth
Perth
PainMedSA-Pain & Rehabilitation Specialists
Wayville
About this study
Official title: Study of Gemini Rechargeable Spinal Cord Stimulation System
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.
- Conditions
- Chronic Pain
- Being tested
- Gemini SCS neuromodulation system
- Keywords
- Gemini rechargeable SCS System, ABT-CIP-10407, IPG
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemini SCS neuromodulation systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemini rechargeable Spinal Cord Stimulation (SCS) System | Experimental | Patients will be implanted with the Gemini rechargeable SCS System Receives: Device: Gemini SCS neuromodulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 weeks (30-45 days) follow-up post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start20 Sep 2022
- Primary completion19 Jan 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590000
- Sponsor's protocol ID
- ABT-CIP-10407
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2022
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gemini Rechargeable Spinal Cord Stimulation System
- ClinicalTrials.gov ID
- NCT05590000
- Acronym / sponsor ID
- ABT-CIP-10407
- Conditions
- Chronic Pain
- Keywords
- Gemini rechargeable SCS System, ABT-CIP-10407, IPG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Posted 24 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemini rechargeable Spinal Cord Stimulation (SCS) System | Experimental | Device: Gemini SCS neuromodulation systemPatients will be implanted with the Gemini rechargeable SCS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement.
- 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.
- 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.
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years at the time of enrollment.
Key exclusion criteria (7 listed)
- Subject's SCS trial was unsuccessful.
- Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott.
- Subject has or will receive more than one IPG.
- Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemini SCS neuromodulation systemThis 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. | Device | Gemini rechargeable Spinal Cord Stimulation (SCS) System |
Primary outcome
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemini SCS neuromodulation system in people with Chronic Pain, run by Abbott Medical Devices at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System (time frame: At 6 weeks (30-45 days) follow-up post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.