NCT07324109 Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
| NCT ID | NCT07324109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Median |
| Condition | Phantom Limb Pain After Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-04-01 with a primary completion date of 2026-07-31.
⚠ 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 tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.
Eligibility Criteria
Inclusion Criteria: * Unilateral major lower-limb amputation (transtibial or transfemoral) * Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3/10 on the Visual Analog Scale (VAS) during the baseline period * Regular daily use of a prosthetic limb (minimum 4 hours/day) * Adequate German language proficiency to understand and complete study questionnaires and follow study procedures * Ability to provide informed consent Exclusion Criteria: * Unstable wound or skin condition at the residual limb * Inconsistent prosthetic use (less than daily or \< 4 hours/day) * Poorly fitting or non-functional prosthesis (as determined by study team) * Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness) * Insufficient German language skills to comprehend study materials or complete assessments reliably
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07324109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Phantom Limb Pain After Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07324109 currently recruiting?
Yes, NCT07324109 is actively recruiting participants. Contact the research team at johannes.schroeter@median-kliniken.de for enrollment information.
Where is the NCT07324109 trial being conducted?
This trial is being conducted at Wiesbaden, Germany.
Who is sponsoring the NCT07324109 clinical trial?
NCT07324109 is sponsored by Median. The trial plans to enroll 20 participants.