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

NCT03956277 | Unknown DMC FDA Device

• 1 other identifier: 1801004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Technical Success of PUG

  proportion of PUG procedures that result in successful placement of a gastrostomy tube

  Immediate

Secondary Outcomes (2)

• SAE Rate

  30 days

• Complication Rate

  30 days

Study Arms (1)

Observational PUG

Patients receive gastrostomy via percutaneous ultrasound gastrostomy.

Device: PUG

Interventions

PUG DEVICE

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

Observational PUG

Eligibility Criteria

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

Study Population

All patients who meet the inclusion and exclusion criteria who are indicated for gastrostomy

You may qualify if:

• Written informed consent must be obtained before any study-specific assessment is performed •Male or female ≥18 years of age•BMI between 20 and 30•Indication for gastrostomy tube placement determined to be present by the primary clinical care team•Patient determined to be an appropriate candidate for PEG or PUG by the study team•Women of childbearing potential must have negative serum or urine pregnancy test duringthe current hospitalization

You may not qualify if:

• BMI \<20 or \> 30•Temperature ≥ 38 C •Systolic BP \< 100 or \> 180 mmHg•Heart Rate \< 50 or \> 110•Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker).•History of prior gastrostomy or gastrectomy (partial or complete).•Patients with hematocrit \<25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding. •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. •Involvement in other investigational trials within 30 days prior to screening.•Any other medical condition(s) that may putthe patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.

Sponsors & Collaborators

• CoapTech: lead
• University of Maryland, Baltimore: collaborator
• University of Maryland, Baltimore Washington Medical Center: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21202, United States

Location

Study Officials

• Gentry Wilkerson

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: December 1, 2019
• Primary Completion: October 14, 2023
• Study Completion: February 4, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)