GastrostomyNCT03956277
Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
An observational study of Gastrostomy, run by CoapTech at 1 site in United States.
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?
- PUG
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 4 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients who meet the inclusion and exclusion criteria who are indicated for gastrostomy
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•BMI between 20 and 30•Indication for gastrostomy tube placement determined to be present by the primary clinical care team•Patient determined to be an appropriate candidate for PEG or PUG by the study team•Women of childbearing potential must have negative serum or urine pregnancy test duringthe current hospitalization
Who cannot join
- •BMI <20 or > 30•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 or gastrectomy (partial or complete).•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 putthe patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21202
About this study
Official title: A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
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 40eligible 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 through Day30 for potential complications.
- Conditions
- Gastrostomy
- Being tested
- PUG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUGDevice
This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).
| Study group | Role | What they receive |
|---|---|---|
| Observational PUG | Patients receive gastrostomy via percutaneous ultrasound gastrostomy. Receives: Device: PUG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of PUG
proportion of PUG procedures that result in successful placement of a gastrostomy tube
Measured: Immediate
Secondary outcomes (2)
SAE Rate
compare the rate of serious complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique.
Measured: 30 days
Complication Rate
compare the rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Dec 2019
- Primary completion14 Oct 2023 (estimated)
- Study completion4 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoapTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, University of Maryland, Baltimore Washington Medical Center
- Responsible party
- Sponsor
- Investigators
- Gentry Wilkerson, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956277
- Sponsor's protocol ID
- 1801004
- Status last verified
- Jan 2023
- First submitted
- 16 May 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. 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
- NCT03956277
- Acronym / sponsor ID
- 1801004
- Conditions
- Gastrostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CoapTechIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, University of Maryland, Baltimore Washington Medical Center
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 14 Oct 2023 (estimated)
- Study completion
- 4 Feb 2024 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
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 40eligible 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 through Day30 for potential complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational PUG | – | Device: PUGPatients receive gastrostomy via percutaneous ultrasound gastrostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion and exclusion criteria who are indicated for gastrostomy
Key inclusion criteria (1 listed)
- •Written informed consent must be obtained before any study-specific assessment is performed •Male or female ≥18 years of age•BMI between 20 and 30•Indication for gastrostomy tube placement determined to be present by the primary clinical care team•Patient determined to be an appropriate candidate for PEG or PUG by the study team•Women of childbearing potential must have negative serum or urine pregnancy test duringthe current hospitalization
Key exclusion criteria (1 listed)
- •BMI <20 or > 30•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 or gastrectomy (partial or complete).•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 putthe patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.
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 |
|---|---|---|
| PUGThis methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf). | Device | Observational PUG |
Primary outcome
Technical Success of PUG
Time frame: Immediate
proportion of PUG procedures that result in successful placement of a gastrostomy tube
2 secondary outcomes
SAE Rate
Time frame: 30 days
Complication Rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Gentry Wilkerson principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy, run by CoapTech at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. 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 United States. 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?
Results are not available in the source record.
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?
Technical Success of PUG (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023.