NCT06858488

Brief Summary

Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2025Jun 2027

First Submitted

Initial submission to the registry

February 12, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

June 22, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 12, 2025

Last Update Submit

June 17, 2025

Conditions

Trauma Injury

Keywords

OrthopedicsExtremity fracture

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the EIT device

    The primary objective of this work is to explore whether changes in impedance measurement associated with EIT are associated with soft tissue injury and readiness for surgical intervention. EIT is a technique which introduces a small amount of electrical current into biologic tissue through an array of electrodes and measures the change in signal to generate images related to the physiology of that tissue.

    20 minutes

Study Arms (1)

Extremity fracture

EXPERIMENTAL

High energy closed extremity fractures

Procedure: Extremity Surgery

Interventions

Extremity SurgeryPROCEDURE

Patients 18 years of age or older with high energy closed extremity fractures. Provision of informed consent.

Extremity fracture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • High energy closed extremity fracture
  • Provision of informed consent

You may not qualify if:

  • Metatarsal fractures
  • Injury to both lower extremities precluding contralateral imaging
  • Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
  • Currently pregnant, potentially pregnant, or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ida L Gitajn, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly B Symonds

CONTACT

603-653-9440Holly.B.Symonds@hitchcock.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief, Orthopaedics

Study Record Dates

First Submitted

February 12, 2025

First Posted

March 5, 2025

Study Start

March 20, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 22, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)