ClinicalTrials.gg
Not yet recruitingNCT07896499Updated Oct 27, 2026

Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy

A Phase 4 interventional study of Geko and control in Post Operative Swelling, sponsored by Cedars-Sinai Medical Center. Not yet recruiting. Open to participants aged 13 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
13 Years to 65 Years
Sex
All
01

Study summary

report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs

Read the detailed description

The purpose of the research is to report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs. The primary research procedures are to report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs, apply device after surgery, and review Patient charts with PT (physical therapy) information. The study will enroll 46 subjects; ages 13 to 65, scheduled to undergo primary unilateral anterior cruciate ligament reconstruction with either bone patella tendon bone, quadriceps tendon or Achillies allograft, subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.

a. Rather than directly stimulating the muscle, FirstKind(company who patented the Geko device) identified a suitable location for accessing the common peroneal nerve where it passes superficially near the skin. By accessing this nerve prior to its deep-superficial branch, FirstKind was able to stimulate two separate complexes of muscles, anterior and lateral muscle enjambment. Stimulating the nerve requires less current and is considerably more comfortable than directly stimulating the muscle, to achieve the same degree of muscle contractions. We have uploaded an information sheet from FirstKind with an illustration of which muscles are stimulated.

02

Conditions studied

  • Post Operative Swelling
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Scheduled to undergo primary unilateral anterior cruciate ligament reconstruction with either bone patella tendon bone, quadriceps tendon or Achillies allograft.

      • Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study

Exclusion criteria

Exclusion Criteria:

    • Any records flagged "break the glass" or "research opt out"

      • Prior ligamentous injury and/or surgery to the operative knee (arthroscopic surgeries allowed), previous ACL surgery of the target knee, previous graft failure, or relevant musculoskeletal impairment
      • Any pain disorder, neuro-muscular disorder, or neuropathy
      • History of opioid or alcohol abuse within past 3 years
      • Open and/or infected wound in the treatment areas or any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes
      • History of sensitive skin
      • History of known to be allergic to acrylic acid
      • History of implanted electronic devices (for example a cardiac pacemaker)
      • History of recently diagnosed or suspected DVT
      • History of cryoglobulinemia
      • History of paroxysmal cold hemoglobinuria
      • History of cold urticaria
      • History of Raynaud's disease
      • Concomitant surgical interventions
      • Recent incision on lateral leg
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    With geko

    Device: Geko

  • Placebo comparator
    control, no geko

    Other: control

Interventions

  • DeviceGeko

    application of Geko device

  • Othercontrol

    no Geko device applied

06

What researchers measure

Primary outcomes

  1. swelling

    Time frame: From enrollment to 90 days after application

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jan 2030, 37 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 27, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896499
Responsible party
Michael Banffy, MD (Physician, Cedars-Sinai Medical Center) — Principal investigator
First posted
Oct 27, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Oct 27, 2026

Study contacts

Karla Echeverri
Contact
karla.echeverri@csmns.org
4243151875 ext. 424 315 1875

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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