Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Study of Gemini Rechargeable Spinal Cord Stimulation System

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Gemini SCS neuromodulation system

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Auchenflower, Australia
    • QPAIN
  • Clayton, Australia
    • Metro Pain Group
  • Hurstville, Australia
    • Sydney Spine & Pain
  • Parramatta, Australia
    • Sydney Pain Management Centre
  • Perth, Australia
    • Pain Care Perth
  • Wayville, Australia
    • PainMedSA-Pain & Rehabilitation Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gemini rechargeable Spinal Cord Stimulation (SCS) System; Patients will be implanted with the Gemini rechargeable SCS System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System	The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.	At 6 weeks (30-45 days) follow-up post implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Gemini rechargeable SCS System; ABT-CIP-10407; IPG
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ABT-CIP-10407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes