NCT04528875

Brief Summary

Utilizing existing data from CT/MRI images of patients, the investigators wish to develop an algorithm for augmenting the image obtained by ultrasound. In order to improved injection by ultrasound guidance

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

August 23, 2020

Last Update Submit

March 9, 2021

Conditions

Image, Body

Keywords

ultrasoundimaginglower backCT, MRI

Outcome Measures

Primary Outcomes (1)

  • Algorithm for imaging augmentation of ultrasound

    1 year

Interventions

Ultrasound imagingDEVICE

Imaging of low back with ultrasound

Eligibility Criteria

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

Patients who are referred to the Rambam Institute of Pain Medicine suffering from low back pain and who have already undergone a CT scan or MRI examination of the lower back before arriving at the Institute

You may qualify if:

  • Patients with low back pain including lower / upper back pain. Patients who underwent MRI or CT imaging of the lower back during the past year.
  • Patients who can understand the rationale of the study and can sign an informed consent form.

You may not qualify if:

  • Patients who have undergone back surgery in the lower back area Patients with significant deformity (deformity) in the back such as scoliosis with an angle above 50 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Simon Vulfsons, M.D.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Vulfsons, M.D.

CONTACT

+972502064890s_vulfsons@rambam.health.gov.il

Amir Minerbi, M.D.

CONTACT

+972502063887a_minerbi@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 27, 2020

Study Start

February 5, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)