Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

NCT05590000 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10407
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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

Keywords

Gemini rechargeable SCS System; ABT-CIP-10407; IPG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gemini rechargeable Spinal Cord Stimulation (SCS) System

EXPERIMENTAL

Patients will be implanted with the Gemini rechargeable SCS System

Device: Gemini SCS neuromodulation system

Interventions

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.

Gemini rechargeable Spinal Cord Stimulation (SCS) System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

QPain

Auchenflower, Australia

Location

Metro Pain Group

Clayton, Australia

Location

Sydney Spine & Pain

Hurstville, Australia

Location

Sydney Pain Management Centre

Parramatta, Australia

Location

Pain Care Perth

Perth, Australia

Location

PainMedSA-Pain & Rehabilitation Specialists

Wayville, Australia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Devyani Nanduri, Senior Director, Clinical & Regulatory Affairs
• Organization: Abbott

devyani.nanduri@abbott.com

+16698329450

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: September 20, 2022
• Primary Completion: January 19, 2023
• Study Completion: February 17, 2023
• Last Updated: October 24, 2023
• Results First Posted: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)