NCT05810077

Brief Summary

Evaluation of ultrasound as a diagnostic tool in assessment of patients with brachial plexus injuries before undergoing surgical exploration

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

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

First Submitted

Initial submission to the registry

March 16, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

March 16, 2023

Last Update Submit

April 26, 2023

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (1)

  • Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) .

    Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) among all patients with brachial plexus injuries then compare our results with operative findings (as the gold standard ) to estimate sensitivity and specificity.

    Within 2 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study sample calculated using Epi . as 36 patients.

You may qualify if:

  • all patients ages with brachial plexus injuries

You may not qualify if:

  • patients underwent brachial plexus surgery before
  • patients with surgical emphysema
  • patients with serious skeletal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hager M Ahmed, Master

    Assist university

    PRINCIPAL INVESTIGATOR

  • Nagham N Mahmood, Professor

    Assist university

    STUDY CHAIR

Central Study Contacts

Hager mohamed Ahmed, Master

CONTACT

01093639662doctorhagerlotfallah@gmail.com

Nagham N Mahmoud, Professor

CONTACT

01028820041naghamnomar@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 16, 2023

First Posted

April 12, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04