Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
CompletedNot applicableNCT05590000
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Study of Gemini Rechargeable Spinal Cord Stimulation System
- Conditions
- Interventions
- Device: Gemini SCS neuromodulation system
- Sponsor
- Abbott Medical Devices
- Start date
- 2022-09-20
- Primary completion
- 2023-01-19
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05590000