Pediatric Percutaneous Ultrasound Gastrostomy Technique

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966311
• Other study ID #: 220001
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: CoapTech
• Contact: Jack Kent, MPH
• Phone: 4102151638
• Email: jack[@]coaptech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy
• Gastrostomy Complications
• Pediatric Disorder
• Ultrasound

Intervention

Device:
• Percutaneous Ultrasound Gastrostomy
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Locations

Country	Name	City	State
United States	Nyph/Cumc	New York	New York
United States	Children's Hospital Of Phildelphia	Philadelphia	Pennsylvania
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
CoapTech	Children's Hospital of Philadelphia, Children's National Research Institute, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 days
Secondary	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	up to 30 days
Secondary	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).	up to 30 days
Secondary	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).	up to 30 days
Secondary	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).	up to 30 days
Secondary	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.	up to 30 days
Secondary	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.	up to 30 days