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

Study Overview
=================
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 up to 25 eligible 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 at date of discharge or Day 30 (whichever is earlier) for potential complications.

Detailed Description
-----------------
Gastrostomy feeding is an established means of delivering adequate nutrition to patients with an inability to meet their metabolic requirements due to inadequate oral intake. Additionally, the gastrostomy tube can be utilized for medication administration in patients unable to otherwise tolerate oral intake. Traditionally, placement of gastrostomy tubes has been performed endoscopically, radiologically or by either laparoscopic or open surgical techniques. More than 200,000 gastrostomy tubes are placed each year in the United States, and that number is expected to increase as the proportion of the population that is elderly grows (Roche et al 2003, Goldberg et al 2005, Lynch et al 2004). Previous studies have failed to identify a clearly superior technique for placement of feeding tubes (Bravo 2016, Yuan 2016). Percutaneous endoscopic gastrostomy (PEG) was first described by Gauderer et al. in 1980 in a case series of 12 children as an alternative to laparotomy in high-risk patients (Gauderer 1980). There is a high overall success rate of PEG placement at 95-100% (Itkin 2011). Percutaneous endoscopic gastrostomy (PEG) has become the most common method for placement of a gastrostomy tube. This requires the use of specialized equipment and the availability of physicians specifically trained in this procedure. The number of procedures performed yearly to place feeding tubes is expected to rise as the population ages and as some treatments have resulted in some diseases become chronic states rather than invariably fatal conditions. Challenges to performance of gastrostomy tube placement include the requirement for specialized equipment, specialized areas designated to have this procedure performed as well as the need for proceduralists who are specifically trained in this technique. The CoapTech device was developed in an effort to reduce the complicated requirements associated with other techniques of gastrostomy placement so that when clinically indicated the procedure can be performed in a safe and timely manner by a wide range of clinicians with various training backgrounds.

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

Conditions
-----------------
Gastrostomy

Intervention / Treatment
-----------------
* Device: Percutaneous Ultrasound Gastrostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent must be obtained before any study-specific assessment is performed Male or female ≥18 years of age 20≤ BMI ≤30 Indication for gastrostomy tube placement determined to be present by the primary clinical care team Patient determined to be an appropriate candidate for gastrostomy by the study team Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization Exclusion Criteria: BMI > 30, or BMI < 20 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, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery. 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 put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study. For example, large or collapsed transverse colon overlapping anterior stomach on pre-existing radiographic scan. Anticipated discharge < 36 hours from gastrostomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>This arm utilizes the investigational device, as specified in protocol. | Device: Percutaneous Ultrasound Gastrostomy<br>* A balloon catheter is inserted into the stomach and used to appose tissue between anterior stomach and skin. Fluid fills the balloon, enabling ultrasound visualization. Then a guidewire is inserted, and pulled out through the mouth to create wire-to-wire (through and through) access. At that point, a gastrostomy tube is placed over it using over-the-wire (push) technique.<br>* Other names: Gastrostomy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Device Related Adverse Events | the number of enrolled subjects who have a serious, adverse event during placement of a gastrostomy tube using the PUG procedure. Adverse events were defined by the Clavien-Dindo classification system of surgical complications. For the purpose of this study, minor adverse events are defined as Grade I-II and serious adverse events as Grade III-V. See references for relevant citation. | Discharge or 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Serious Device Related Adverse Events | the severity of any serious, device-related adverse event during placement of a gastrostomy tube using the PUG procedure (if applicable). Adverse events were defined by the Clavien-Dindo classification system of surgical complications. For the purpose of this study, minor adverse events are defined as Grade I-II and serious adverse events as Grade III-V. See references for relevant citation. | Discharge or 30 days | 
| Number of Participants With Technically Successful Gastrostomy Tube Placement | the number of enrolled subjects who have successful placement of a gastrostomy tube | Discharge or 30 days | 
| Length of Angiographic Suite Usage | Length of angiographic suite usage in minutes | Discharge or 30 days |