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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03956277
Other study ID # 1801004
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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