N/A
Completed N=25
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Source: ClinicalTrials.gov NCT05590000 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05590000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.