Transdermal Compress for Transfemoral Amputations

Transdermal Compress IDE Study

Recruiting N/A Interventional Study
Prosthesis and Implants
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Balmoral Medical company · Industry
Who this trial is looking for

This trial is looking for adults aged 18 to 60 who have lost a leg above the knee and have difficulty using traditional prosthetics. Participants will use a new device designed to help with mobility and will engage in follow-up evaluations and rehabilitation.

Are You a Good Fit for This Trial?
Rules you out Severe peripheral vascular diseaseDiabetes mellitusOsteomyelitisSevere metabolic disorders

You may be able to join if

  • I am between 18 and 60 years old.
  • I have lost my leg above the knee.
  • I have a body mass index (BMI) between 18.5 and 40.
  • I cannot use a conventional prosthesis or have problems with them.
  • I am willing and able to participate in follow-up evaluations.
  • I understand the purpose of the study and can give my consent.

You may not be able to join if

  • I am pregnant, nursing, or plan to become pregnant in the next year.
  • I have had an infection at my amputation site in the last 6 months.
  • I have a history of severe vascular disease or diabetes.
  • I have previously had a device implanted in my leg that is similar to the one in this study.
  • I have a history of severe metabolic disorders affecting my bones.
  • I currently smoke or have used tobacco in the last 6 months.
  • I have a condition that my doctor thinks would prevent me from participating.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria 1. Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures. 2. Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Partic…
Contacts

Mary Thacker

1-978-760-3826

BAL-448-001@capstonedevservices.com

CONTACT