Pediatric Percutaneous Ultrasound Gastrostomy Technique

NCT ID: NCT05966311

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-12-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Ultrasound Gastrostomy (PUG)

Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist

Group Type: EXPERIMENTAL

Percutaneous Ultrasound Gastrostomy

Intervention Type: DEVICE

Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Percutaneous Radiologic Gastrostomy

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Percutaneous Ultrasound Gastrostomy

Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Intervention Type: DEVICE

Other Intervention Names

Ultrasound Gastrostomy; PUG; PUMA-G Pediatric Procedure

Eligibility Criteria

Inclusion Criteria

• 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)
• 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

Exclusion Criteria

• 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).
• 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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: collaborator

CoapTech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's National Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Nyph/Cumc

New York, New York, United States

Site Status: RECRUITING

Children's Hospital Of Phildelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jack Kent, MPH

Role: CONTACT

jack@coaptech.com

4102151638

Steven Tropello, MD

Role: CONTACT

steven@coaptech.com

4348255184

Facility Contacts

Bhupender Yadav, MD

Role: primary

byadav@childrensnational.org

202-476-4252

Joshua Weintraub, MD

Role: primary

jw750@cumc.columbia.edu

212-326-8874

Anne Marie Cahill, MD

Role: primary

CAHILL@chop.edu

267-425-7118

Other Identifiers

220001

Identifier Type: -

Identifier Source: org_study_id