UMEM Research Studies

Percutaneous Ultrasound Gastrostomy technique

Sponsor: CoapTech | Status: Recruiting

Start Date: 08/01/2019 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)
Michael McCurdy
Daniel Haase
Kami Windsor
WanTsu Wendy Chang

Description:

Title: A single-center, feasibility study to evaluate the use and safety of the Percutaneous Ultrasound Gastrostomy technique 

Primary Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM

Research Team: 

Dana Beach (dbeach3@som.umaryland.edu)

Kyra Lasko (kyra.lasko@som.umaryland.edu)

Youssef Annous (yannous@som.umaryland.edu)

Objectives: to evaluate the performance, safety and tolerability of the FDA-approved Percutaneous Ultrasound Gastrostomy procedure that utilizes a novel device in conjunction with widely available ultrasound technology

Study design: 

This is a single-center, non-randomized, non-blinded, prospective, observational data collection 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. This device, the PUMA-G system, received clearance by the FDA in April 2019 and is now in clinical use at sites in the United States. The research team will recruit 40 eligible subjects who have been indicated for the PUG procedure by their care team. Patients will be assessed at baseline and followed for 2 days following performance of PUG to assess for potential complications.  If the patient remains hospitalized they will be assessed through Day 30 for all potential complications.

Primary Endpoint(s): 

To determine the proportion of PUG procedures that result in successful placement of a gastrostomy tube in patients in whom the clinical care team has determined the need for feeding tube placement for administration of nutrition or medications

Secondary Endpoints:

1- Rate of SAEs: Compare the rate of serious complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique

2- Complication rate: compare the rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique

 

Keywords: Gastrostomy, Percutaneous Ultrasound Gastrostomy, PUG, Feeding tube