N/A
N=50
A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
Gastrostomy
Bottom Line
View on ClinicalTrials.gov: NCT03575754 ↗Enrolled (actual)
50
Serious AEs
14.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Serious Device Related Adverse Events — 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous Ultrasound Gastrostomy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CoapTech
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Device Related Adverse Events |
1; 5 | — |
| SECONDARY Severity of Serious Device Related Adverse Events |
1; 5; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Technically Successful Gastrostomy Tube Placement |
25; 25 | — |
| SECONDARY Length of Angiographic Suite Usage |
68; 39.3 | — |
Summary
This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology. The procedure will be performed in up to 25 eligible subjects. Patients will be followed for 2 days following performance of PUG to assess for potential complications. If the patient remains hospitalized they will be assessed at date of discharge or Day 30 (whichever is earlier) for potential complications.
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any study-specific assessment is performed
- Male or female ≥18 years of age
- 20≤ BMI ≤30
- Indication for gastrostomy tube placement determined to be present by the primary clinical care team
- Patient determined to be an appropriate candidate for gastrostomy by the study team
- Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization
Exclusion Criteria
- BMI > 30, or BMI 180 mmHg
- Heart Rate 110
- Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker).
- History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
- Patients with hematocrit <25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
- 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.
- Involvement in other investigational trials within 30 days prior to screening.
- Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study. For example, large or collapsed transverse colon overlapping anterior stomach on pre-existing radiographic scan.
- Anticipated discharge < 36 hours from gastrostomy.
Data sourced from ClinicalTrials.gov (NCT03575754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.