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NCT04080011 · ClinicalTrials.gov registry record · NA
A Case Series Study of Negative Pressure Platform Wound Device
A NA study of Incisions, Surgical, sponsored by The Metis Foundation.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04080011: Completed NA study of Incisions, Surgical, sponsored by The Metis Foundation.
NCT04080011 is a NA study of Incisions, Surgical that has completed, run by The Metis Foundation. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04080011, a NA study of Incisions, Surgical, has completed, sponsored by The Metis Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.
Primary Outcome
Safety is assessed by recording each adverse event (AE) occurring during the period the patient has the study device applied and throughout the entire enrollment period.
Conditions Studied
Interventions
- DEVICE NP-PWD
Study Locations (1)
Texas
- Northeast Baptist - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-08-30 |
| Est. Completion | 2019-12-11 |
| Phase | NA |
What the finished NCT04080011 record still lists
NCT04080011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Incisions, Surgical appearing as the primary indexed condition, and to 1 intervention - of which NP-PWD is the first listed.
NCT04080011 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04080011 about?
NCT04080011 is a clinical study titled "A Case Series Study of Negative Pressure Platform Wound Device". This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gathe...
What is the current status of trial NCT04080011?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-08-30. Estimated completion is 2019-12-11.
What conditions does trial NCT04080011 study?
This clinical trial studies the following conditions: Incisions, Surgical.
What interventions are being tested in trial NCT04080011?
The interventions under investigation include: NP-PWD (DEVICE).
Who is sponsoring clinical trial NCT04080011?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04080011 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04080011's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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