Bioimpedance for Ortho Trauma

NCT ID: NCT06858488

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Extremity fracture

High energy closed extremity fractures

Group Type EXPERIMENTAL

Extremity Surgery

Intervention Type PROCEDURE

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

Interventions

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Extremity Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth College

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ida Leah Gitajn

Section Chief, Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ida L Gitajn, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Holly B Symonds

Role: CONTACT

603-653-9440

Facility Contacts

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Ida L Gitajn, MD

Role: primary

603-650-5000

Other Identifiers

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STUDY02002529

Identifier Type: -

Identifier Source: org_study_id

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