RECRUITING

A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants with Transfemoral Amputations

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

The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.

Official Title

A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants with Transfemoral Amputations

Quick Facts

Study Start:2024-06-11
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06134167

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kristen Gault
CONTACT
(508) 351-8632
kristen.gault@avaniaclinical.com

Principal Investigator

David Recker, M.D.
STUDY_DIRECTOR
Balmoral

Study Locations (Sites)

UC Davis Medical Center
Sacramento, California, 95817
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Walter Reed Military Medical Center
Washington, District of Columbia, 20814
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Penn Medicine; University of Pennsylvania Health System
Philidelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburg, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Balmoral Medical company

  • David Recker, M.D., STUDY_DIRECTOR, Balmoral

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 Date2024-06-11
Study Completion Date2031-06

Study Record Updates

Study Start Date2024-06-11
Study Completion Date2031-06

Terms related to this study

Additional Relevant MeSH Terms

  • Prosthesis and Implants