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

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

NCT03956277•CoapTech

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

December 1, 2019

Primary Completion Date

October 14, 2023

Completion Date

February 4, 2024

Last Updated

October 19, 2023

Enrollment

ACTUAL participants

Conditions

Gastrostomy

Interventions

PUG

DEVICE

Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

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Gastrostomy ComplicationsGastrostomy

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RECRUITINGNA

Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.

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Gastrostomy

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RECRUITINGNA

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.

Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

RCT: Early Feeding After PEG Placement

The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy

Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study