NCT07713563

Brief Summary

The goal of this feasibility study is to learn if individuals without formal radiology training can safely acquire adequate x-ray images following a structured training and real-time remote guidance from a licensed radiologic technologist (RT). The main question it aims to answer is:

  1. 1.Can trained non-radiology staff, with real-time remote supervision, obtain x-ray images that meet preset technical quality standards for each required view?
  2. 2.Can these staff perform x-ray exams safely, as shown by low operator exposure, few image re-takes, and good adherence to radiation safety protocols?
  3. 3.What is the mental and physical workload for the non-radiology staff and the remote RT during the imaging process, as measured by the NASA Raw Task Load Survey (RTLX) after each session?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 17, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

18 days

First QC Date

July 6, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

X-ray imagingRemote supervisionNon-radiology personnelImage adequacyRadiation safetyOperator workloadUpskilingTraining

Outcome Measures

Primary Outcomes (1)

  • Proportion of x-ray images rated as "diagnostically accurate"

    Remote RT rates diagnostic adequacy of each image using a structured evaluation form

    Immediately following each x-ray image acquisition

Secondary Outcomes (3)

  • Operator radiation exposure

    60 minutes from start of each imaging session

  • X-ray operator reported workload

    Within 24 hours from imaging session

  • X-ray operator qualitative interview

    Within one week of imaging session

Other Outcomes (4)

  • Total number of retakes per imaging session

    Immediately following each imaging session

  • Time to complete an imaging session

    60 minutes from start of each imaging session

  • Compliance with imaging and safety procedures

    60 minutes from start of first image acquisition

  • +1 more other outcomes

Study Arms (1)

X-ray Operator

EXPERIMENTAL

Participants will complete a structured training, covering imaging technique, radiation safety procedures, and operation of the portable x-ray system. Following training, participants will perform a series of x-ray image acquisitions under real-time remote supervision by a licensed RT and complete a qualitative interview and workload assessment.

Other: X-ray Operator Training

Interventions

The structured training will cover core principles of radiography, positioning techniques, and how to use the ENDURO DR ES90 portable x-ray system. Additionally, participants will complete a self-paced radiation safety training course consisting of radiation safety protocols and operator safety principles.

X-ray Operator

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 or older
  • Able to read, speak, and understand English sufficient to follow study instructions and complete evaluation
  • Able to provide verbal consent
  • Currently employed as a medical assistant in a clinical or outpatient setting or actively enrolled in an accredited medical assistant training program
  • Willing to wear a personal dosimeter and comply with all radiation safety procedures
  • Willing to participate in all trainings

You may not qualify if:

  • Prior or current professional training, certification, or education in radiography (formal or informal)
  • Prior experience performing x-rays
  • a) including any prior hands-on testing experience with the ENDURO DR ES90 portable x-ray (prior observation or exposure to ENDURO DR is permitted)
  • Pregnancy or possible pregnancy (self-report)
  • Any condition or circumstance that would make participation unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham

Somerville, Massachusetts, 02145, United States

Location

Study Officials

  • David Levine, MD, MPH, MA

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a prospective, single-arm, simulation-based study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of Research & Development at Healthcare at Home at Mass General Brigham

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 20, 2026

Study Start

May 17, 2026

Primary Completion

June 4, 2026

Study Completion

June 25, 2026

Last Updated

July 20, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations