MedTrace Logo

Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique

NCT03956277 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-10-19

No results posted yet for this study

Summary

This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology. The procedure will be performed in 40eligible subjects. Patients will be followed for 2 days following performance of PUG to assess for potential complications. If the patient remains hospitalized they will be assessed through Day30 for potential complications.

Conditions

  • Gastrostomy

Interventions

DEVICE

PUG

This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • University of Maryland, Baltimore Washington Medical Center

    collaborator UNKNOWN

  • CoapTech

    lead INDUSTRY

Principal Investigators

  • Gentry Wilkerson · University of Maryland, Baltimore

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-10-14
Completion
2024-02-04
FDA Device
Yes

Countries

  • United States

Study Locations

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 NCT03956277 on ClinicalTrials.gov