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Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

Unknown statusNot applicableNCT04580732
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.

Study details

Official title
Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study
Interventions
  • Device: MiniStim PNS
Sponsor
MiniStim LLC
Organization
Uro Medical Corporation
Start date
2021-05-05
Primary completion
2024-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: A. Capable of giving informed consent and willing to follow all study related procedures; B. Women and men \>18 years of age; C. Baseline VAS score of \> 5; D. History of chronic, function-limiting knee pain of at least three months; E. Not had recent surgical procedures of the knee within the last three months; F. ≥50% temporary relief from temporary nerve diagnostics; G. No evidence of anatomic abnormalities that could jeopardize the placement of the device; H. Able to operate programmer, recharger, study assessments and provide accurate responses; I. Appropriate candidate for the implant procedure based on the opinion of investigator. Exclusion Criteria: A. An active implantable electronic device regardless of whether stimulation is ON or OFF; B. Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.); C. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study; D. Subject noted no relief from temporary nerve diagnostics; E. Inability to achieve appropriate positioning; F. Inability to understand informed consent and protocol; G. Conditions requiring recurring MRI evaluation or diathermy procedures; H. Anatomical restrictions such that device placement is not possible; I. Have a life expectancy of less than 1-year; J. Worker's compensation claimants; K. Based on opinion of investigator any legal concerns that would preclude his/her enrollment in the study or potentially confound results; L. Deemed unsuitable for enrollment by investigator based on medical history or physical examination.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04580732