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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05590000




Registration number
NCT05590000
Ethics application status
Date submitted
18/10/2022
Date registered
21/10/2022
Date last updated
24/10/2023

Titles & IDs
Public title
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Scientific title
Study of Gemini Rechargeable Spinal Cord Stimulation System
Secondary ID [1] 0 0
ABT-CIP-10407
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Gemini SCS neuromodulation system

Experimental: Gemini rechargeable Spinal Cord Stimulation (SCS) System - Patients will be implanted with the Gemini rechargeable SCS System


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
Timepoint [1] 0 0
At 6 weeks (30-45 days) follow-up post implant

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2023
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
QPain - Auchenflower
Recruitment hospital [2] 0 0
Metro Pain Group - Clayton
Recruitment hospital [3] 0 0
Sydney Spine & Pain - Hurstville
Recruitment hospital [4] 0 0
Sydney Pain Management Centre - Parramatta
Recruitment hospital [5] 0 0
Pain Care Perth - Perth
Recruitment hospital [6] 0 0
PainMedSA-Pain & Rehabilitation Specialists - Wayville
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Hurstville
Recruitment postcode(s) [4] 0 0
- Parramatta
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Wayville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05590000
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05590000