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Portable Ultrasound for Interventional Procedures

NCT04685330 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-12-28

No results posted yet for this study

Summary

We are evaluating whether a portable ultrasound can be safely and effectively used in portable interventional procedures, whether the image quality can be improved to meet standard existing ultrasounds. In the COVID-19 pandemic, transferring patients with COVID-19 to the procedure room results in contamination and shut down of those rooms while also putting folks in transit at some degree of transmission risk. The ability to do procedures at bedside can alleviate those risks greatly.

Conditions

  • Ultrasound Therapy; Complications

Interventions

PROCEDURE

Ultrasound guided procedure

Single-arm, open-label device efficacy study to enroll 200 patients who have been ordered to have an ultrasound-guided procedure by the MGH Interventional Radiology department, including paracentesis, thoracentesis, biopsy, or ultrasound-guided drain placement. Patients will be restricted to adults who can consent.

DEVICE

Portable ultrasound

The FDA approved Healcerion SONON portable ultrasound (linear and curved) will be used during clinically indicated standard ultrasound-guided procedures following clinical standard of care. A standard clinical ultrasound will subsequently be used for image guidance as the gold standard. Images will be compared and improved. The efficacy of the portable ultrasound will be monitored by the clinical user and any complications within 30 days will be determined by chart review.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ralph Weissleder, MD, PhD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685330 on ClinicalTrials.gov