Trial Outcomes & Findings for A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique (NCT NCT03575754)

Last Updated: 2021-02-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Discharge or 30 days

Results posted on

2021-02-03

Participant Flow

Study recruitment began Oct 2018 and concluded Apr 2020. Patients referred to Interventional Radiology for gastrostomy tube placement were approached for consent at least 24hrs pre-procedure in clinic or in hospital. When patients lacked capacity to consent, a surrogate decision maker was approached or reached remotely for telephone consent.

No pre-assignment methods were employed in this protocol

Participant milestones

Participant milestones
Measure	Prospective PUG Cohort Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional n=25 Participants This arm utilizes the investigational device, as specified in protocol. 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.	Matched Retrospective RIG Cohort n=25 Participants Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants	10 Participants n=4 Participants	23 Participants n=27 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Age, Continuous	64 years STANDARD_DEVIATION 15 • n=93 Participants	66 years STANDARD_DEVIATION 14 • n=4 Participants	65 years STANDARD_DEVIATION 15 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	21 Participants n=93 Participants	0 Participants n=4 Participants	21 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	25 Participants n=4 Participants	25 Participants n=27 Participants

PRIMARY outcome

Timeframe: Discharge or 30 days

Outcome measures

Outcome measures
Measure	Prospective PUG Cohort n=25 Participants Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 Participants Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Number of Participants With Serious Device Related Adverse Events	1 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prospective PUG Cohort n=25 Participants Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 Participants Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Severity of Serious Device Related Adverse Events Grade IIIB: Complications requiring surgical, endoscopic or radiological intervention w anesthesia	0 Participants	0 Participants
Severity of Serious Device Related Adverse Events Grade IV: Life-threatening complications	0 Participants	0 Participants
Severity of Serious Device Related Adverse Events Grade V: Death of patient	0 Participants	0 Participants
Severity of Serious Device Related Adverse Events Grade IIIA: Complications requiring surgical, endoscopic or radiological intervention w/o anesthesia	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Discharge or 30 days

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

Outcome measures

Outcome measures
Measure	Prospective PUG Cohort n=25 Participants Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 Participants Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Number of Participants With Technically Successful Gastrostomy Tube Placement	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Discharge or 30 days

Population: 22 of the participants in the Prospective PUG Cohort and 25 participants in the Matched Retrospective RIG Cohort were analyzed in this group as each received gastrostomy procedure within the Angiosuite. 3 participants in the Prospective PUG Cohort were excluded in this analysis as procedures were performed at the bedside on the Intensive Care Unit (ICU).

Length of angiographic suite usage in minutes

Outcome measures

Outcome measures
Measure	Prospective PUG Cohort n=22 Participants Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 Participants Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Length of Angiographic Suite Usage	68 minutes Standard Deviation 24.5	39.3 minutes Standard Deviation 15

Adverse Events

Prospective PUG Cohort

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Matched Retrospective RIG Cohort

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prospective PUG Cohort n=25 participants at risk Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 participants at risk Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	4.0% 1/25 • Number of events 1 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.	0.00% 0/25 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.
Gastrointestinal disorders Gastrostomy Tube Failure	0.00% 0/25 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.	20.0% 5/25 • Number of events 5 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.
Gastrointestinal disorders Abdominal Wall Abscess	4.0% 1/25 • Number of events 1 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.	0.00% 0/25 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.

Other adverse events

Other adverse events
Measure	Prospective PUG Cohort n=25 participants at risk Patients meeting all the inclusion criteria and none of the exclusion criteria and provided study consent who received the Percutaneous Ultrasound Gastrostomy (PUG) procedure	Matched Retrospective RIG Cohort n=25 participants at risk Patients who previously received the standard of care Radiologic Inserted Gastrostomy (RIG) procedure. A waiver of consent was provided by the Research Ethics Board for this study arm.
Respiratory, thoracic and mediastinal disorders Mild Aspiration	4.0% 1/25 • Number of events 1 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.	8.0% 2/25 • Number of events 2 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.
Infections and infestations Local Stomal Site Infection	8.0% 2/25 • Number of events 2 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.	0.00% 0/25 • At least 48hrs post-procedure until discharge from hospital or 30 days post-procedure (whichever came sooner) All cause adverse events observed in study participants 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 major adverse events as Grade III-V.

Additional Information

Dr. Derek Cool

London Health Sciences Centre

Phone: 519-685-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place