Post Operative SwellingPhase 4NCT07896499
Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
A Phase 4 study testing Geko in people with Post Operative Swelling, run by Cedars-Sinai Medical Center.
Trial 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 more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Swelling
- What is being tested?
- Geko
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial of the Geko™ Device in Prevention of Pain and Swelling Following Anterior Cruciate Ligament Knee Arthroscopy
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.
- 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.
- Conditions
- Post Operative Swelling
- Being tested
- Geko, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GekoDevice
application of Geko device
controlOther
no Geko device applied
| Study group | Role | What they receive |
|---|---|---|
| With geko | Experimental | Not described Receives: Device: Geko |
| control, no geko | Placebo comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
swelling
Measured: From enrollment to 90 days after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative SwellingStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896499
- Sponsor's protocol ID
- STUDY00004050
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Geko™ Device in Prevention of Pain and Swelling Following Anterior Cruciate Ligament Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT07896499
- Acronym / sponsor ID
- STUDY00004050
- Conditions
- Post Operative Swelling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With geko | Experimental | Device: Geko |
| control, no geko | Placebo comparator | Other: control |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Scheduled to undergo primary unilateral anterior cruciate ligament reconstruction with either bone patella tendon bone, quadriceps tendon or Achillies allograft.
Key exclusion criteria (15 listed)
- • Any records flagged "break the glass" or "research opt out"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gekoapplication of Geko device | Device | With geko |
| controlno Geko device applied | Other | control, no geko |
Primary outcome
swelling
Time frame: From enrollment to 90 days after application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Geko in people with Post Operative Swelling, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla Echeverri (4243151875 ext. 424 315 1875, karla.echeverri@csmns.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
swelling (time frame: From enrollment to 90 days after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.