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NCT05590000

Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Completed NA Results posted Last updated 24 October 2023
What this trial tests

NA trial testing Gemini SCS neuromodulation system in Chronic Pain in 25 participants. Completed in 17 February 2023.

Timeline
20 September 2022
Primary endpoint
19 January 2023
17 February 2023

Quick facts

Lead sponsorAbbott Medical Devices
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment25
Start date20 September 2022
Primary completion19 January 2023
Estimated completion17 February 2023
Sites6 locations across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.

GroupValue95% CI
Gemini Rechargeable Spinal Cord Stimulation (SCS) System0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks after the permanent implant procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Serious: 0/24 (0%)
Deaths: 0/24
Other adverse events (1 terms — click to expand)

ReactionSystemGemini Rechargeable Spinal…
CEREBROSPINAL FLUID LEAKAGENervous system disorders

Data from ClinicalTrials.gov NCT05590000 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other Abbott Medical Devices trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05590000.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing