Trials / Unknown
UnknownNCT03956277
Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- CoapTech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 40eligible 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 through Day30 for potential complications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PUG | This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf). |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2023-10-14
- Completion
- 2024-02-04
- First posted
- 2019-05-20
- Last updated
- 2023-10-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03956277. Inclusion in this directory is not an endorsement.