Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

NCT ID: NCT05590000

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-02-17

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Gemini rechargeable Spinal Cord Stimulation (SCS) System

Patients will be implanted with the Gemini rechargeable SCS System

Group Type: EXPERIMENTAL

Gemini SCS neuromodulation system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QPain

Auchenflower, , Australia

Metro Pain Group

Clayton, , Australia

Sydney Spine & Pain

Hurstville, , Australia

Sydney Pain Management Centre

Parramatta, , Australia

Pain Care Perth

Perth, , Australia

PainMedSA-Pain & Rehabilitation Specialists

Wayville, , Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10407

Identifier Type: -

Identifier Source: org_study_id