Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Chronic Pain Clinical Trial

Official title:

Study of Gemini Rechargeable Spinal Cord Stimulation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590000
• Other study ID #: ABT-CIP-10407
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: February 17, 2023

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 17, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Australia	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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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