RECRUITING

BACK4 Safety Evaluation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To characterize the safety of combined RF and EMS therapies with the BACK4 device in healthy volunteers. Subjects will receive 3 treatments of increasing intensity over a one week period.

Official Title

Safety Evaluation of BACK4 Device

Quick Facts

Study Start:2025-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07153900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 22-55 years old
  2. * Able to provide written informed consent
  1. * Injury within the past 30 days
  2. * Cancer or cancerous lesions in the treatment area
  3. * Skin disorders (e.g., eczema, shingles), skin burns, or open wounds
  4. * Coagulation disorders, phlebitis, or thrombophlebitis
  5. * Insensitivity to heat
  6. * Local insensitivity to pain and/or touch
  7. * Fever, bacterial infection, infectious disease, or tuberculosis
  8. * Severe hypertension or hypotension
  9. * Electrical implants (e.g., pacemaker, insulin pump, neurostimulator)
  10. * History of seizures or recent surgery
  11. * Known hypersensitivity to device materials
  12. * Pregnant or breastfeeding women
  13. * Participation in another clinical trial within 30 days

Contacts and Locations

Study Contact

Ramona von Leden, PhD
CONTACT
(530) 383-2292
ramona@winback.com

Study Locations (Sites)

RORE Method
Birmingham, Michigan, 48009
United States

Collaborators and Investigators

Sponsor: SWIMS America Corp.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-09
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • muscle stimulation
  • topical heating

Additional Relevant MeSH Terms

  • Safety and Tolerability in Healthy Subjects