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

Gastrostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03956277
• Other study ID #: 1801004
• Status: Active, not recruiting
• Start date: December 1, 2019
• Est. completion date: February 4, 2024

Study information

• Verified date: January 2023
• Source: CoapTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 4, 2024
• Est. primary completion date: October 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• •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

Exclusion Criteria:

• •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.

Related Conditions & MeSH terms

• Gastrostomy

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
CoapTech	University of Maryland, Baltimore, University of Maryland, Baltimore Washington Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success of PUG	proportion of PUG procedures that result in successful placement of a gastrostomy tube	Immediate
Secondary	SAE Rate	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.	30 days
Secondary	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.	30 days