Trials / Completed
CompletedNCT05590000
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Study of Gemini Rechargeable Spinal Cord Stimulation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gemini 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. |
Timeline
- Start date
- 2022-09-20
- Primary completion
- 2023-01-19
- Completion
- 2023-02-17
- First posted
- 2022-10-21
- Last updated
- 2023-10-24
- Results posted
- 2023-10-24
Locations
6 sites across 1 country: Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05590000. Inclusion in this directory is not an endorsement.