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Procedure
Ultrasound-Guided Feeding Tube Placement for Pediatric Disorders
N/A
Recruiting
Research Sponsored by CoapTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study Summary
This trial tests an investigational device using ultrasound & magnets to help place feeding tubes in children safely & accurately.
Who is the study for?
This trial is for children needing gastrostomy tube placement due to various conditions like throat abnormalities, neurological issues, bowel diseases, or failure to thrive. Candidates must weigh at least 3kg and have an abdominal wall thickness ≤3cm. They can't participate if they have a fever, abnormal blood pressure or coagulation levels, metallic implants affected by magnets, prior stomach surgeries, recent involvement in other trials, pregnancy or lactation.Check my eligibility
What is being tested?
The study tests the PUMA-G Pediatric System—a new device using ultrasound and magnets—to see how well it helps doctors insert feeding tubes in kids. It's designed for safe use during different phases based on the child's weight.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort at the insertion site, possible infection risk from tube placement procedures and any complications arising from magnet and ultrasound equipment usage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PUMA-G Pediatric System Device-Related Complication Rate
Secondary outcome measures
Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications
Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Percutaneous Ultrasound Gastrostomy (PUG)Experimental Treatment1 Intervention
Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist
Group II: Percutaneous Radiologic GastrostomyActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous Ultrasound Gastrostomy
2018
N/A
~30
Find a Location
Who is running the clinical trial?
CoapTechLead Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Gastrostomy
65 Patients Enrolled for Gastrostomy
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,582,940 Total Patients Enrolled
Columbia UniversityOTHER
1,433 Previous Clinical Trials
2,447,179 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unusual organ placement or a very small stomach.I have unusual spinal shapes or my organs are not in the usual places.I have had surgery or trauma to my stomach area in the past.I need a feeding tube due to specific health issues or conditions.I have a condition affecting my esophagus such as narrowing, blockage, or damage from swallowing harmful substances.My weight is between 3kg and 10kg.I have scoliosis.My hemoglobin is below 7g/dL, or I've recently had a blood transfusion or been fluid resuscitated, or I'm currently experiencing severe GI bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Percutaneous Ultrasound Gastrostomy (PUG)
- Group 2: Percutaneous Radiologic Gastrostomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this clinical trial?
"This trial is seeking 80 applicants between infancy and 21 years old who require gastrostomy."
Answered by AI
Are there any current vacancies on this research project for participants?
"Affirmative, according to clinicaltrials.gov the examination is recruiting patients currently. The research was first published on July 7th 2023 and underwent its most recent update a few weeks later on 27th of that same month. From three different sites they are looking to recruit 80 participants in total."
Answered by AI
Is this medical study open to those of a more senior age?
"Qualifying criteria for this trial state that subjects must be between 0 and 21 years old. 16 research trials are accepting patients below the age of majority, while 15 studies are recruiting adults above 65."
Answered by AI
What is the current enrollment quota for this research endeavor?
"Affirmative. Details available on clinicaltrials.gov suggest that this trial is still open to participants, having initially been posted July 7th 2023 and last updated July 27th 2023. The goal of the study is to recruit 80 patients from 3 sites."
Answered by AI
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