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
NCT number | NCT05966311 |
Other study ID # | 220001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 7, 2023 |
Est. completion date | December 31, 2024 |
Verified date | March 2024 |
Source | CoapTech |
Contact | Jack Kent, MPH |
Phone | 4102151638 |
jack[@]coaptech.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
CoapTech | Children's Hospital of Philadelphia, Children's National Research Institute, Columbia University |
United States,
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 |
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