Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Gemini SCS neuromodulation system

• Registration Number: NCT05590000
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Primary Completion: 2023-01-19
• Study Completion: 2023-02-17
• Status Verified: 2023-10
• Results First Submitted: 2023-10-01
• Results First Submitted QC: 2023-10-01
• Last Update Submitted: 2023-10-01
• Results First Posted: 2023-10-24
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemini rechargeable Spinal Cord Stimulation (SCS) System	Gemini SCS neuromodulation system	Patients will be implanted with the Gemini rechargeable SCS System

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

QPain; 🇦🇺 Auchenflower, Australia

Metro Pain Group; 🇦🇺 Clayton, Australia

Sydney Spine & Pain; 🇦🇺 Hurstville, Australia

Sydney Pain Management Centre; 🇦🇺 Parramatta, Australia

PainMedSA-Pain & Rehabilitation Specialists; 🇦🇺 Wayville, Australia

Pain Care Perth; 🇦🇺 Perth, Australia