Gastrostomy
Conditions
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.
Interventions
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.
Sponsors
London Health Sciences Centre
CoapTech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Device Related Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Serious Device Related Adverse Events | 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. |
| Number of Participants With Technically Successful Gastrostomy Tube Placement | Discharge or 30 days | the number of enrolled subjects who have successful placement of a gastrostomy tube |
| Length of Angiographic Suite Usage | Discharge or 30 days | Length of angiographic suite usage in minutes |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
No pre-assignment methods were employed in this protocol
Participants by arm
| Arm | Count |
|---|---|
| Interventional 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. | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Interventional | Matched Retrospective RIG Cohort |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 12 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 13 Participants | 10 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 15 | 64 years STANDARD_DEVIATION 15 | 66 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 0 Participants | 25 Participants |
| Race (NIH/OMB) White | 21 Participants | 21 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 46 Participants | 23 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 2 / 25 |
| serious Total, serious adverse events | 2 / 25 | 5 / 25 |
Outcome results
Primary
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.
Time frame: Discharge or 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective PUG Cohort | Number of Participants With Serious Device Related Adverse Events | 1 Participants |
| Matched Retrospective RIG Cohort | Number of Participants With Serious Device Related Adverse Events | 5 Participants |
Secondary
Length of Angiographic Suite Usage
Length of angiographic suite usage in minutes
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective PUG Cohort | Length of Angiographic Suite Usage | 68 minutes | Standard Deviation 24.5 |
| Matched Retrospective RIG Cohort | Length of Angiographic Suite Usage | 39.3 minutes | Standard Deviation 15 |
Secondary
Number of Participants With Technically Successful Gastrostomy Tube Placement
the number of enrolled subjects who have successful placement of a gastrostomy tube
Time frame: Discharge or 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective PUG Cohort | Number of Participants With Technically Successful Gastrostomy Tube Placement | 25 Participants |
| Matched Retrospective RIG Cohort | Number of Participants With Technically Successful Gastrostomy Tube Placement | 25 Participants |
Secondary
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.
Time frame: Discharge or 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prospective PUG Cohort | Severity of Serious Device Related Adverse Events | Grade IIIA: Complications requiring surgical, endoscopic or radiological intervention w/o anesthesia | 1 Participants |
| Prospective PUG Cohort | Severity of Serious Device Related Adverse Events | Grade IV: Life-threatening complications | 0 Participants |
| Prospective PUG Cohort | Severity of Serious Device Related Adverse Events | Grade IIIB: Complications requiring surgical, endoscopic or radiological intervention w anesthesia | 0 Participants |
| Prospective PUG Cohort | Severity of Serious Device Related Adverse Events | Grade V: Death of patient | 0 Participants |
| Matched Retrospective RIG Cohort | Severity of Serious Device Related Adverse Events | Grade IV: Life-threatening complications | 0 Participants |
| Matched Retrospective RIG Cohort | Severity of Serious Device Related Adverse Events | Grade IIIA: Complications requiring surgical, endoscopic or radiological intervention w/o anesthesia | 5 Participants |
| Matched Retrospective RIG Cohort | Severity of Serious Device Related Adverse Events | Grade IIIB: Complications requiring surgical, endoscopic or radiological intervention w anesthesia | 0 Participants |
| Matched Retrospective RIG Cohort | Severity of Serious Device Related Adverse Events | Grade V: Death of patient | 0 Participants |