RECRUITING

Pediatric Percutaneous Ultrasound Gastrostomy Technique

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Conditions

GastrostomyGastrostomy ComplicationsPediatric DisorderUltrasoundPediatric GastrostomyDevice FeasibilityDevice SafetyPOCUS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy

Quick Facts

Study Start:2023-07-07
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05966311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed
  2. * Weight ≥5 (Phase 0, Phase 1, Phase 2)
  3. * Weight ≥3kg and \<10kg (Phase 3)
  4. * Estimated abdominal wall thickness ≤3cm
  5. * Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:
  6. * Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)
  7. * Neurologic: Head trauma, Cerebral palsy
  8. * Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption
  9. * Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal
  10. * Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team
  11. * Anticipated discharge \> 24 hrs following gastrostomy
  1. * Temperature ≥ 38 C
  2. * Systolic BP \< 80 or \> 180 mmHg
  3. * Heart Rate \< 50 or \> 160
  4. * Estimated abdominal wall thickness \>3cm
  5. * Coagulopathy defined by INR \> 1.7 or Platelets \<50,000
  6. * Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).
  7. * History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
  8. * Scoliosis
  9. * Atypical organ placement including microgastria
  10. * Involvement in other investigational trials within 30 days prior to screening,
  11. * 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
  12. * Patients with HgB \< 7g/dL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding
  13. * Esophageal Diseases: Atresia, stricture, caustic ingestion
  14. * Spinal anomalies or atypical organ placement
  15. * 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.

Contacts and Locations

Study Contact

Jack Kent, MPH
CONTACT
4102151638
jack@coaptech.com
Steven Tropello, MD
CONTACT
4348255184
steven@coaptech.com

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States
Nyph/Cumc
New York, New York, 10019
United States
Children's Hospital Of Phildelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: CoapTech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-07-07
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Gastrostomy
  • Pediatric Gastrostomy
  • Device Feasibility
  • Device Safety
  • Ultrasound
  • POCUS

Additional Relevant MeSH Terms

  • Gastrostomy
  • Gastrostomy Complications
  • Pediatric Disorder
  • Ultrasound