NCT03575754

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: CoapTech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrostomy

Interventions

Type	Name	Description
DEVICE	Percutaneous Ultrasound Gastrostomy	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.

Timeline

• Start date: 2018-10-22
• Primary completion: 2020-04-17
• Completion: 2020-07-10
• First posted: 2018-07-03
• Last updated: 2021-02-03
• Results posted: 2021-01-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study