GastrostomyNCT05966311
Pediatric Percutaneous Ultrasound Gastrostomy Technique
A study testing Percutaneous Ultrasound Gastrostomy in people with Gastrostomy and Gastrostomy Complications, run by CoapTech at 3 sites in United States.
Trial summary
The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Gastrostomy, Gastrostomy Complications, Pediatric Disorder
- 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
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jul 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed
- Weight ≥5 (Phase 0, Phase 1, Phase 2)
- Weight ≥3kg and <10kg (Phase 3)
- Estimated abdominal wall thickness ≤3cm
- Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:
- Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)
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- Neurologic: Head trauma, Cerebral palsy
- Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption
- Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal
- Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team
- Anticipated discharge > 24 hrs following gastrostomy
Who cannot join
- Temperature ≥ 38 C
- Systolic BP < 80 or > 180 mmHg
- Heart Rate < 50 or > 160
- Estimated abdominal wall thickness >3cm
- Coagulopathy defined by INR > 1.7 or Platelets <50,000
- Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).
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- History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
- Scoliosis
- Atypical organ placement including microgastria
- Involvement in other investigational trials within 30 days prior to screening,
- 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
- Patients with HgB < 7g/dL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding
- Esophageal Diseases: Atresia, stricture, caustic ingestion
- Spinal anomalies or atypical organ placement
- Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, based on the performance of a pre-procedural assessment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Nyph/Cumc
New York, New York, 10019
Joshua Weintraub, MD, 212-326-8874, jw750@cumc.columbia.edu
- Recruiting
Children's Hospital Of Phildelphia
Philadelphia, Pennsylvania, 19104
Anne Marie Cahill, MD, 267-425-7118, CAHILL@chop.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Bhupender Yadav, MD, 202-476-4252, byadav@childrensnational.org
About this study
Official title: A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.
Read the detailed description
This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the pediatric population.
A common method for placing gastrostomy tubes currently uses ionizing radiation to aid doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to guide gastrostomy feeding tube placement.
Up to 40 patients will be enrolled in the study and receive the PUG procedure using the PUMA-G Pediatric System. Following the procedure, patients will be followed during their hospital admission until discharge or up to 30 days. Data will be collected to assess how safe the procedure was and if the procedure used less radiation. Study subjects will be compared to a matched, retrospective cohort of patients who received standard of care gastrostomy tube placement by Interventional Radiology.
- Conditions
- Gastrostomy, Gastrostomy Complications, Pediatric Disorder, Ultrasound
- Being tested
- Percutaneous Ultrasound Gastrostomy
- Keywords
- Gastrostomy, Pediatric Gastrostomy, Device Feasibility, Device Safety, Ultrasound, POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Ultrasound GastrostomyDevice
Also called Ultrasound Gastrostomy, PUG, PUMA-G Pediatric Procedure
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Ultrasound Gastrostomy (PUG) | Experimental | Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist Receives: Device: Percutaneous Ultrasound Gastrostomy |
| Percutaneous Radiologic Gastrostomy | No intervention | A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUMA-G Pediatric System Device-Related Complication Rate
A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve
Measured: up to 30 days
Secondary outcomes (6)
Gastrostomy Procedure Complication Rate
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 standard of care Interventional Radiologic gastrostomy tube placement method
Measured: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by total fluoroscopic time (min).
Measured: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by dose area product (microGy-m2).
Measured: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by skin dose (mGy).
Measured: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications
The quantity of anesthesia/sedative medications used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medications and total procedural dosages will be quantified.
Measured: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications
The quantity of antibiotic medications used during the PUG procedure and in the post-procedural timeframe will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medication and dosage will be measured.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start7 Jul 2023
- Primary completion30 Aug 2028 (estimated)
- Study completion31 Dec 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants prospectively enrolled are assigned to the interventional treatment procedure using the PUMA-G Peds System. A retrospective comparator is used as a means of comparing outcomes with a similar, historical cohort of patients who received the standard of care treatment procedure.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoapTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia, Columbia University, Children's National Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966311
- Sponsor's protocol ID
- 220001
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2023
- Last updated
- 31 Jul 2026
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
- ClinicalTrials.gov ID
- NCT05966311
- Acronym / sponsor ID
- 220001
- Conditions
- Gastrostomy, Gastrostomy Complications, Pediatric Disorder, Ultrasound
- Keywords
- Gastrostomy, Pediatric Gastrostomy, Device Feasibility, Device Safety, Ultrasound, POCUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CoapTechIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia, Columbia University, Children's National Research Institute
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jul 2023 (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.
The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.
Detailed description
This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the pediatric population.
A common method for placing gastrostomy tubes currently uses ionizing radiation to aid doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to guide gastrostomy feeding tube placement.
Up to 40 patients will be enrolled in the study and receive the PUG procedure using the PUMA-G Pediatric System. Following the procedure, patients will be followed during their hospital admission until discharge or up to 30 days. Data will be collected to assess how safe the procedure was and if the procedure used less radiation. Study subjects will be compared to a matched, retrospective cohort of patients who received standard of care gastrostomy tube placement by Interventional Radiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants prospectively enrolled are assigned to the interventional treatment procedure using the PUMA-G Peds System. A retrospective comparator is used as a means of comparing outcomes with a similar, historical cohort of patients who received the standard of care treatment procedure.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Ultrasound Gastrostomy (PUG) | Experimental | Device: Percutaneous Ultrasound GastrostomyEnrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist |
| Percutaneous Radiologic Gastrostomy | No intervention | –A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed
- Weight ≥5 (Phase 0, Phase 1, Phase 2)
- Weight ≥3kg and <10kg (Phase 3)
- Estimated abdominal wall thickness ≤3cm
- Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:
Key exclusion criteria (15 listed)
- Temperature ≥ 38 C
- Systolic BP < 80 or > 180 mmHg
- Heart Rate < 50 or > 160
- Estimated abdominal wall thickness >3cm
- Coagulopathy defined by INR > 1.7 or Platelets <50,000
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: Ultrasound Gastrostomy, PUG, PUMA-G Pediatric ProcedureUltrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System | Device | Percutaneous Ultrasound Gastrostomy (PUG) |
Primary outcome
PUMA-G Pediatric System Device-Related Complication Rate
Time frame: up to 30 days
A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve
6 secondary outcomes
Gastrostomy Procedure Complication Rate
Time frame: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)
Time frame: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
Time frame: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)
Time frame: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications
Time frame: up to 30 days
Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- 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.
3 sites 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 and Gastrostomy Complications, run by CoapTech at 3 sites 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Kent, MPH (4102151638, jack@coaptech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUMA-G Pediatric System Device-Related Complication Rate (time frame: up to 30 days). 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 31 Jul 2026.