The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
| Group | Value | 95% CI |
|---|---|---|
| Gemini Rechargeable Spinal Cord Stimulation (SCS) System | 0 |
Last reviewed · How we verify
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
NA trial testing Gemini SCS neuromodulation system in Chronic Pain in 25 participants. Completed in 17 February 2023.
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 20 September 2022 |
| Primary completion | 19 January 2023 |
| Estimated completion | 17 February 2023 |
| Sites | 6 locations across Australia |
Abbott Medical Devices — full company profile →
18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
| Group | Value | 95% CI |
|---|---|---|
| Gemini Rechargeable Spinal Cord Stimulation (SCS) System | 0 |
Time frame: 6 weeks after the permanent implant procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Gemini Rechargeable Spinal… |
|---|---|---|
| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | — |
Data from ClinicalTrials.gov NCT05590000 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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