Geko® T3 One vs Two Study

NCT07849257 | Completed

• 1 other identifier: FSK-LEG-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study to assess the haemodynamic effects of unilateral and bilateral geko® T3 stimulation on lower-limb circulation, measured by femoral artery and vein blood flow.

Conditions

Healthy Adult Participants

Keywords

Blood Circulation; Neuromuscular Electrostimulation; Muscle Contraction; Increase Venous Return

Outcome Measures

Primary Outcomes (4)

• Femoral vein peak systolic velocity during geko® T3 stimulation

  Femoral vein peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.

  During a single study visit of approximately 2.5 hours

• Femoral vein volume flow during geko® T3 stimulation

  Femoral vein volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.

  During a single study visit of approximately 2.5 hours

• Femoral artery peak systolic velocity during geko® T3 stimulation

  Femoral artery peak systolic velocity (PSV), measured in cm/s using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.

  During a single study visit of approximately 2.5 hours

• Femoral artery volume flow during geko® T3 stimulation

  Femoral artery volume flow, measured in mL/min using Doppler ultrasound, was assessed across baseline (no stimulation), unilateral stimulation and bilateral stimulation phases.

  During a single study visit of approximately 2.5 hours

Other Outcomes (5)

• Occurrence of adverse events (AEs)

  Single study visit (approximately 2.5 hours)

• Occurrence of serious adverse events (SAEs)

  Single study visit (approximately 2.5 hours)

• Occurrence of adverse device effects (ADEs)

  Single study visit (approximately 2.5 hours)

Study Arms (1)

Experimental : Single experimental arm: geko® T3 NMES

EXPERIMENTAL

Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit.

Device: NMES

Interventions

NMES DEVICE

Exploring Haemodynamic Effects of Unilateral vs Bilateral NMES of the Lower Limb.

Experimental : Single experimental arm: geko® T3 NMES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• No known history of vascular or neurological conditions affecting the lower limbs.
• Able to read, understand, and communicate in English to ensure informed consent and safe participation in the study.

You may not qualify if:

• Presence of any condition that contraindicates the use of neuromuscular electrical stimulation (e.g., implanted pacemaker, epilepsy)
• Current or recent injury to the lower limbs that may interfere with stimulation or measurement
• Anatomical variations in the femoral artery or vein, specifically vascular branching outside expected anatomical locations, as identified by ultrasound, which may impair accurate blood flow measurement or device placement
• Currently participating in another interventional or physiological research study, or having done so within the past 30 days
• Currently pregnant

Sponsors & Collaborators

• Kieron.Day: lead

Study Sites (1)

Firstkind

High Wycombe, HP11 1JX, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Affairs

Model Details: Single-centre, within-subject, comparative study in healthy volunteers. Each participant will undergo baseline (no stimulation), unilateral, and bilateral geko® T3 neuromuscular electrostimulation (NMES) stimulation in a fixed order within a single visit.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: September 30, 2026
• Study Start: December 9, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

GB (1)