NCT03824444 (AEA PODS) is a EARLY_PHASE1 clinical trial of PODS in Transhumeral Amputation, sponsored by VA Office of Research and Development.

Who is sponsoring NCT03824444?

NCT03824444 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT03824444?

Interventions in NCT03824444: PODS.

What condition does NCT03824444 study?

NCT03824444 studies Transhumeral Amputation.

Is NCT03824444 still recruiting?

NCT03824444 is currently withdrawn. Last updated 26 January 2024.

Last reviewed 2024-01-26 · How we verify

NCT03824444: AEA PODS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EFS Functional Expectations of Transhumeral Percutaneous OI Patients

Withdrawn EARLY_PHASE1 Last updated 26 January 2024

What this trial tests

EARLY_PHASE1 trial testing PODS in Transhumeral Amputation. Withdrawn.

Timeline

1 January 2024

Primary endpoint
23 January 2024

23 January 2024

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Start date	1 January 2024
Primary completion	23 January 2024
Estimated completion	23 January 2024
Sites	1 location across United States

Drugs / interventions tested

PODS

Conditions studied

Transhumeral Amputation — all drugs for Transhumeral Amputation →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Transhumeral Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. The Primary Aim of this proposal is to perform an FDA guided EFS of a percutaneous osseointegrated (OI) docking system for patients with transhumeral (above elbow) amputations, establishing its initial safety. Success of the Primary Aim (Safety) will be determined over a one year follow-up period by observing the rate of patients successfully using their device without removal. The Secondary Aim of this proposal is to quantify the functional effectiveness of the OI device, giving specific attention to protocol differences required for male and female patients. Success for the Secondary Aim (Functional Effectiveness) will be to determine functional improvement with the device compared to the pre-operative performance. This will be the first longitudinal analyses to evaluate the percutaneous OI devices on objective functionality measures of transhumeral amputation individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Extended physiological proprioception is affected by transhumeral Socket-Suspended prosthesis use.
Dunn JA, Wong B, Sinclair SK, Henninger HB, et al · · 2024 · cited 2× · PMID 38513398 · DOI 10.1016/j.jbiomech.2024.112054

Verify or expand the search:

Other recruiting trials for Transhumeral Amputation

Currently open trials in the same condition.

NCT06853938 — Optimizing Transhumeral Osseointegration Prosthesis Control · NA · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03824444 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 26 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824444.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing