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

NCT03575754 | Completed Results DMC FDA Device

• 1 other identifier: 1801001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of Serious Device Related Adverse Events

  Discharge or 30 days

• Number of Participants With Technically Successful Gastrostomy Tube Placement

  Discharge or 30 days

• Length of Angiographic Suite Usage

  Discharge or 30 days

Study Arms (1)

Interventional

EXPERIMENTAL

This arm utilizes the investigational device, as specified in protocol.

Device: Percutaneous Ultrasound Gastrostomy

Interventions

Percutaneous Ultrasound Gastrostomy DEVICE

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.

Also known as: Gastrostomy

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any study-specific assessment is performed
• Male or female ≥18 years of age
• ≤ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CoapTech: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Accorsi F, Chung J, Mujoomdar A, Wiseman D, Kribs S, Cool DW. Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial. Abdom Radiol (NY). 2021 Nov;46(11):5377-5385. doi: 10.1007/s00261-021-03200-x. Epub 2021 Jul 9.

  PMID: 34240242 DERIVED

MeSH Terms

Interventions

Gastrostomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Results Point of Contact

• Title: Dr. Derek Cool
• Organization: London Health Sciences Centre

derek.cool@lhsc.on.ca

519-685-8500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 3, 2018
• Study Start: October 22, 2018
• Primary Completion: April 17, 2020
• Study Completion: July 10, 2020
• Last Updated: February 3, 2021
• Results First Posted: January 14, 2021

Record last verified: 2021-01

Locations

CA (1)