Portable Ultrasound for Interventional Procedures

NCT04685330 | Unknown FDA Device

• 1 other identifier: 2020P003984
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Efficacy > 80%

  Efficacy as defined by the operator in successfully completing the procedure using the portable ultrasound. Reported % of cases the portable ultrasound successfully completed the procedure, stratified by procedure type.

  Approximately 3 years

Study Arms (1)

Adult patients undergoing an ultrasound-guided procedure

Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy

Procedure: Ultrasound guided procedure; Device: Portable ultrasound

Interventions

Ultrasound guided procedure 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.

Adult patients undergoing an ultrasound-guided procedure

Portable ultrasound DEVICE

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.

Adult patients undergoing an ultrasound-guided procedure

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy

You may qualify if:

• The subject has read, signed, and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
• Age ≥ 18 years at the date of informed consent form signature and having the ability to comply with the protocol.
• Undergoing a clinically indicated ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy.

You may not qualify if:

• Patient or health care proxy does not consent
• Patient not undergoing an ultrasound-guided procedure.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Officials

• Ralph Weissleder, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avik Som, MD

CONTACT

+1-832-330-7557; Avik.Som@MGH.HARVARD.EDU

Hyungsoon Im, PhD

CONTACT

+1-617-643-5679; im.hyungsoon@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share