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Device

PODS for Elbow Amputation (AEA PODS Trial)

Phase < 1
Waitlist Available
Led By Kent N. Bachus, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

AEA PODS Trial Summary

This trial is to study a percutaneous osseointegrated (OI) docking system for patients with transhumeral (above elbow) amputations, to establish its initial safety and to quantify the functional effectiveness of the OI device.

Who is the study for?
This trial is for adults with above-elbow amputations who have used or are using a socket-based prosthesis. Participants must be willing to attend all study evaluations, travel to Salt Lake City for a funded 3-day visit, and provide consent. Pregnant individuals, those on renal dialysis, with conditions affecting the limbs' bone/soft tissue, significant physical limitations or other medical issues that could interfere with the study are excluded.Check my eligibility
What is being tested?
The trial is testing a percutaneous osseointegrated (OI) docking system designed for people with transhumeral amputations. It aims to establish initial safety over one year of use without removal and measure functional improvement compared to pre-operative performance.See study design
What are the potential side effects?
While specific side effects aren't listed in this summary, potential risks may include infection at the implant site, skin irritation around the device entry point, discomfort or pain associated with device use, and possible injury to surrounding tissues.

AEA PODS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device rate of safety
Secondary outcome measures
Effectivenss of device to increase in function

AEA PODS Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Implant and followup

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,433 Total Patients Enrolled
Kent N. Bachus, PhDPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT

Media Library

PODS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03824444 — Phase < 1
Elbow Amputation Research Study Groups: Treatment
Elbow Amputation Clinical Trial 2023: PODS Highlights & Side Effects. Trial Name: NCT03824444 — Phase < 1
PODS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824444 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still ongoing?

"The specifications provided on clinicaltrials.gov indicate that this trial is no longer seeking volunteers, as the posting was last edited on October 6th 2022. Despite this, there are 1 other studies recruiting participants currently."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
VA Salt Lake City Health Care System, Salt Lake City, UT
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. VA Salt Lake City Health Care System, Salt Lake City, UT: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
EFS Functional Expectations of Transhumeral Percutaneous OI Patients
2024. "EFS Functional Expectations of Transhumeral Percutaneous OI Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03824444.
~0 spots leftby Apr 2025
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