NCT03575754

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

Completed NA Results posted Last updated 3 February 2021

What this trial tests

NA trial testing Percutaneous Ultrasound Gastrostomy in Gastrostomy in 25 participants. Completed in 10 July 2020.

Timeline

22 October 2018

Primary endpoint
17 April 2020

10 July 2020

Quick facts

Lead sponsor	CoapTech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	22 October 2018
Primary completion	17 April 2020
Estimated completion	10 July 2020
Sites	1 location across Canada

Drugs / interventions tested

• Percutaneous Ultrasound Gastrostomy

Conditions studied

• Gastrostomy — all drugs for Gastrostomy →

Sponsor

CoapTech

Who can join

18 and older, any sex, with Gastrostomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious Device Related Adverse Events Primary · Discharge or 30 days

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.

Group	Value	95% CI
Prospective PUG Cohort	1
Matched Retrospective RIG Cohort	5

Severity of Serious Device Related Adverse Events Secondary · Discharge or 30 days

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.

Grade IIIA: Complications requiring surgical, endoscopic or radiological intervention w/o anesthesia

Group	Value	95% CI
Prospective PUG Cohort	1
Matched Retrospective RIG Cohort	5

Grade IIIB: Complications requiring surgical, endoscopic or radiological intervention w anesthesia

Group	Value	95% CI
Prospective PUG Cohort	0
Matched Retrospective RIG Cohort	0

Grade IV: Life-threatening complications

Group	Value	95% CI
Prospective PUG Cohort	0
Matched Retrospective RIG Cohort	0

Grade V: Death of patient

Group	Value	95% CI
Prospective PUG Cohort	0
Matched Retrospective RIG Cohort	0

Number of Participants With Technically Successful Gastrostomy Tube Placement Secondary · Discharge or 30 days

the number of enrolled subjects who have successful placement of a gastrostomy tube

Group	Value	95% CI
Prospective PUG Cohort	25
Matched Retrospective RIG Cohort	25

Length of Angiographic Suite Usage Secondary · Discharge or 30 days

Length of angiographic suite usage in minutes

Group	Value	95% CI
Prospective PUG Cohort	68	± 24.5
Matched Retrospective RIG Cohort	39.3	± 15

Adverse events — posted to ClinicalTrials.gov

Time frame: At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prospective PUG Cohort

Serious: 2/25 (8%)

Deaths: 1/25

Matched Retrospective RIG Cohort

Serious: 5/25 (20%)

Deaths: 0/25

Serious adverse events (3 terms)

Reaction	System	Prospective PUG Cohort	Matched Retrospective RIG …
Gastrostomy Tube Failure	Gastrointestinal disorders	—	—
Aspiration Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal Wall Abscess	Gastrointestinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Prospective PUG Cohort	Matched Retrospective RIG …
Mild Aspiration	Respiratory, thoracic and mediastinal disorders	—	—
Local Stomal Site Infection	Infections and infestations	—	—

Most-reported serious reactions: Gastrostomy Tube Failure, Aspiration Pneumonia, Abdominal Wall Abscess.

Data from ClinicalTrials.gov NCT03575754 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial.
   Accorsi F, Chung J, Mujoomdar A, Wiseman D, et al · · 2021 · cited 6× · PMID 34240242 · DOI 10.1007/s00261-021-03200-x