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Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Gemini SCS neuromodulation system
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring Gemini rechargeable SCS System, ABT-CIP-10407, IPG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • QPain
  • Metro Pain Group
  • Sydney Spine & Pain
  • Sydney Pain Management Centre
  • Pain Care Perth
  • PainMedSA-Pain & Rehabilitation Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemini rechargeable Spinal Cord Stimulation (SCS) System

Arm Description

Patients will be implanted with the Gemini rechargeable SCS System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2022
Last Updated
October 1, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05590000
Brief Title
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Official Title
Study of Gemini Rechargeable Spinal Cord Stimulation System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Gemini rechargeable SCS System, ABT-CIP-10407, IPG

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemini rechargeable Spinal Cord Stimulation (SCS) System
Arm Type
Experimental
Arm Description
Patients will be implanted with the Gemini rechargeable SCS System
Intervention Type
Device
Intervention Name(s)
Gemini SCS neuromodulation system
Intervention Description
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 Outcome Measure Information:
Title
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
Description
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
Time Frame
At 6 weeks (30-45 days) follow-up post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
QPain
City
Auchenflower
Country
Australia
Facility Name
Metro Pain Group
City
Clayton
Country
Australia
Facility Name
Sydney Spine & Pain
City
Hurstville
Country
Australia
Facility Name
Sydney Pain Management Centre
City
Parramatta
Country
Australia
Facility Name
Pain Care Perth
City
Perth
Country
Australia
Facility Name
PainMedSA-Pain & Rehabilitation Specialists
City
Wayville
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

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