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NCT05966311 · ClinicalTrials.gov registry record · NA
Pediatric Percutaneous Ultrasound Gastrostomy Technique
A NA study of Pediatric Disorder and Gastrostomy, sponsored by CoapTech.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT05966311: Recruiting NA study of Pediatric Disorder and Gastrostomy, sponsored by CoapTech.
NCT05966311 is a NA study of Pediatric Disorder and Gastrostomy that is actively recruiting participants, run by CoapTech. The registered enrollment target is 80 participants, above the 52-participant average among 6 other Pediatric Disorder trials with a reported enrollment target (54% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05966311, a NA study of Pediatric Disorder and Gastrostomy, is actively recruiting participants, sponsored by CoapTech.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study 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. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Percutaneous Ultrasound Gastrostomy
Study Locations (3)
District of Columbia
- Children's National Hospital - Washington D.C.
New York
- Nyph/Cumc - New York
Pennsylvania
- Children's Hospital Of Phildelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
What NCT05966311 shows while recruiting
NCT05966311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 52-participant average among 6 other Pediatric Disorder trials with a reported enrollment target (54% higher).
The record links to 4 conditions, with Pediatric Disorder appearing as the primary indexed condition, and to 1 intervention - of which Percutaneous Ultrasound Gastrostomy is the first listed.
NCT05966311 reports a single indexed study location in District of Columbia, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05966311 about?
NCT05966311 is a clinical study titled "Pediatric Percutaneous Ultrasound Gastrostomy Technique". 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 mag...
What is the current status of trial NCT05966311?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2023-07-07. Estimated completion is 2024-12-31.
What conditions does trial NCT05966311 study?
This clinical trial studies the following conditions: Pediatric Disorder, Gastrostomy, Ultrasound, Gastrostomy Complications.
What interventions are being tested in trial NCT05966311?
The interventions under investigation include: Percutaneous Ultrasound Gastrostomy (DEVICE).
Who is sponsoring clinical trial NCT05966311?
This trial is sponsored by CoapTech, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05966311 being conducted?
This trial has 3 study locations across District of Columbia, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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