Last reviewed · How we verify
NCT04391257
Study of gekoTM Interaction With Cardiac Pacemakers
NA trial testing geko™ in Stroke in 28 participants. Completed in 25 November 2021.
25 November 2021
Quick facts
| Lead sponsor | Firstkind Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 28 |
| Start date | 4 December 2020 |
| Primary completion | 25 November 2021 |
| Estimated completion | 25 November 2021 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- geko™
Conditions studied
- Stroke — all drugs for Stroke →
- Wound Heal — all drugs for Wound Heal →
- Edema Leg — all drugs for Edema Leg →
- Cardiac Pacemaker Electrical Interference — all drugs for Cardiac Pacemaker Electrical Interference →
Sponsor
Firstkind Ltd
Who can join
18 and older, any sex, with Stroke or Wound Heal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers. There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson's Electronically (STRIPE trial): a randomised control trial of tibial nerve stimulation for bladder symptoms in Parkinson's disease using a self-contained wearable device.
Smith MD, Tenison E, Drake MJ, Ben-Shlomo Y, et al · · 2022 · cited 7× · PMID 36307874 · DOI 10.1186/s13063-022-06827-3
Verify or expand the search:
- PubMed search for NCT04391257
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Firstkind Ltd trials
Trials by the same sponsor.
- NCT07197996 — The RETRAIN Trial Phase 2 · NA · recruiting
- NCT05476913 — GEKO Venous Thromboembolism Prevention Study · NA · recruiting
- NCT04927234 — Foot and Ankle Post-operative Oedema Management Using Geko™ · NA · completed
- NCT05057793 — Efficacy Study for Geko Device in VLU Patients (Canada) · NA · terminated
- NCT04309110 — Efficacy of Adhesive Strength of New Hydrogel Formulation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04391257 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Firstkind Ltd
- Last refreshed: 5 August 2022
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/NCT04391257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing