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Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

NCT07571239 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved Altius® system. Subjects will be followed longitudinally and will complete a series of patient-reported outcome measure questionnaires, a study intake questionnaire which assesses demographics, amputation and prosthesis history, and medical/medication history.

Conditions

  • Amputation; Lower Extremity
  • Pain, Persistent Postsurgical

Interventions

DEVICE

Surgical Implantation

The Altius system will be surgically implanted into the patient on one occasion. The Altius system is then used on an 'as needed' basis by patient.

Sponsors & Collaborators

Principal Investigators

  • Jacques Hacquebord, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2028-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571239 on ClinicalTrials.gov