NCT07273422 Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.
| NCT ID | NCT07273422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spectrum Ergonomics and Occupational Health Services |
| Condition | No Applicable Condition; Study of Physiologic Monitor Alarms |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-06 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-06 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the effectiveness of newly developed self-powered, smart insoles that will be used for remote patient monitoring (RPM) for both military and civilian populations. The present study is part of a project funded by SEMI and the Air Force Research Laboratory (AFRL).
Eligibility Criteria
Inclusion Criteria: 1. Participant is generally health and between 18 and 90 year of age at time of signing consent. 2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week. \- Exclusion Criteria: * Age of Participants: 18-90 Sample Size: At Utah: All Centers: 120 Inclusion Criteria: Inclusion criteria for Phase 1 and Phase 2 pilot studies at UofU 1\. Participant is generally healthy and between 18 and 90 years of age at time of signing consent 2. Participant must be able to walk comfortably for 1 mile. 3. Will seek 5 male and 5 female participants. Inclusion criteria for Phase 2 field studies conducted by Spectrum Ergonomics 1. Participant is generally health and between 18 and 90 year of age at time of signing consent. 2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week. Exclusion Criteria: Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU * Flat feet (Pes planus) * Unilateral leg amputee * Females who are pregnant, \< 3 months postpartum, or currently lactating. * Major surgery \< 6 months or minor surgery \< 3 months before enrollment. * Major infections such as sepsis or pneumonia \< 3 months before enrollment. * Myocardial infarction or heart failure \< 5 years or less before enrollment. * Ankle fusion or total replacement * Morbid obesity BMI \> 40. Exclusion Criteria for Phase 2 field study at Spectrum Ergonomics * Flat feet (Pes planus) or high arches (Pes cavus) * Unilateral leg amputee. * Brittle Diabetes- hard-to-control diabetes (also called labile diabetes), which is characterized by wide variations in blood glucose in which blood glucose levels can quickly move from too high (hyperglycemia) to too low (hypoglycemia). * Peripheral neuropathy. * Loss of sensation in the sole of foot. * Open wound on the foot. * Females who are pregnant, \< 3 months postpartum, or currently lactating. * Ankle fusion or total replacement * Major surgery \< 6 months or minor surgery \< 3 months before enrollment. * Major infections such as sepsis or pneumonia \< 3 months before enrollment. * Myocardial infarction or heart failure \< 1 years before enrollment. * Morbid obesity BMI \> 40.
Contact & Investigator
Robert Andosca, PhD
PRINCIPAL INVESTIGATOR
Inviza Health
Frequently Asked Questions
Who can join the NCT07273422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying No Applicable Condition; Study of Physiologic Monitor Alarms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273422 currently recruiting?
Yes, NCT07273422 is actively recruiting participants. Contact the research team at spectrumergonomics@gmail.com for enrollment information.
Where is the NCT07273422 trial being conducted?
This trial is being conducted at Williamsport, United States.
Who is sponsoring the NCT07273422 clinical trial?
NCT07273422 is sponsored by Spectrum Ergonomics and Occupational Health Services. The principal investigator is Robert Andosca, PhD at Inviza Health. The trial plans to enroll 150 participants.