GastrostomyNCT03575754
A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
A study testing Percutaneous Ultrasound Gastrostomy in people with Gastrostomy, run by CoapTech at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy
- What is being tested?
- Percutaneous Ultrasound Gastrostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2018to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Victoria Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
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.
Read the 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
- Being tested
- Percutaneous Ultrasound Gastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Ultrasound GastrostomyDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | This arm utilizes the investigational device, as specified in protocol. Receives: Device: Percutaneous Ultrasound Gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Discharge or 30 days
Secondary outcomes (3)
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.
Measured: Discharge or 30 days
Number of Participants With Technically Successful Gastrostomy Tube Placement
the number of enrolled subjects who have successful placement of a gastrostomy tube
Measured: Discharge or 30 days
Length of Angiographic Suite Usage
Length of angiographic suite usage in minutes
Measured: Discharge or 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start22 Oct 2018
- Primary completion17 Apr 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoapTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575754
- Sponsor's protocol ID
- 1801001
- Status last verified
- Jan 2021
- First submitted
- 18 Jun 2018
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 15273542Accorsi 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.
PubMed 34240242
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
- ClinicalTrials.gov ID
- NCT03575754
- Acronym / sponsor ID
- 1801001
- Conditions
- Gastrostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CoapTechIndustry (pharma, biotech, devices)
- Collaborators
- London Health Sciences Centre
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Percutaneous Ultrasound GastrostomyThis arm utilizes the investigational device, as specified in protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Ultrasound GastrostomyAlso: GastrostomyA 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. | Device | Interventional |
Primary outcome
Number of Participants With Serious Device Related Adverse Events
Time frame: 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.
3 secondary outcomes
Severity of Serious Device Related Adverse Events
Time frame: Discharge or 30 days
Number of Participants With Technically Successful Gastrostomy Tube Placement
Time frame: Discharge or 30 days
Length of Angiographic Suite Usage
Time frame: Discharge or 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15273542Dindo 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.
- Derived from this study: PubMed 34240242Accorsi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Ultrasound Gastrostomy in people with Gastrostomy, run by CoapTech at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Device Related Adverse Events (time frame: Discharge or 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.