Clinical trial NCT03956277: Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
Official title: A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrostomy
Lead sponsor: CoapTech
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland, Baltimore
name: University of Maryland, Baltimore Washington Medical Center
First posted: 2019-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion and exclusion criteria who are indicated for gastrostomy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success of PUG
timeFrame: Immediate
Secondary outcomes:
measure: SAE Rate
timeFrame: 30 days
measure: Complication Rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Gentry Wilkerson
role: PRINCIPAL_INVESTIGATOR
References: