Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QPain, Auchenflower, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemini SCS neuromodulation system

Device

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.

Primary outcomes

Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Study of Gemini Rechargeable Spinal Cord Stimulation System

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 21, 2022
Registry last updated: Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed