Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Study Details
Study Description
Brief Summary
This is a pre-market, prospective, single-arm, non-randomized, open-label, multi-center, international clinical study designed to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.
The study is designed to report on 20 subjects who receive a Gemini SCS implant and complete follow-up. The clinical investigation will be conducted at up to 8 centers in Australia.
Subjects participating in this clinical investigation will be followed for approximately 6 weeks after the permanent implant procedure. The expected duration of enrollment is 5 months. The total duration of the clinical investigation is expected to be 8 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gemini rechargeable Spinal Cord Stimulation (SCS) System Patients will be implanted with the Gemini rechargeable SCS System |
Device: Gemini rechargeable Spinal Cord Stimulation (SCS) System
Patients with chronic pain will be implanted with Gemini rechargeable SCS System
|
Outcome Measures
Primary Outcome Measures
- Confirmatory Safety Endpoint: The rate of serious adverse events related to the investigational IPG and/or charging system [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | QPain | Auchenflower | Australia | ||
| 2 | Metro Pain Group | Clayton | Australia | ||
| 3 | Sydney Spine & Pain | Hurstville | Australia | ||
| 4 | Sydney Pain Management Centre | Parramatta | Australia | ||
| 5 | Pain Care Perth | Perth | Australia | ||
| 6 | PainMedSA-Pain & Rehabilitation Specialists | Wayville | Australia |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABT-CIP-10407