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NCT04149522 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer
A Phase 2 study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04149522 is a Phase 2 study that was terminated before completion, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 40 participants.
The verdict
NCT04149522, a Phase 2 study, was terminated before completion, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.
Interventions
- DEVICE Mepitel Film®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 2 |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04149522
The ClinicalTrials.gov registry entry for NCT04149522 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mepitel Film® is the first listed.
NCT04149522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04149522 about?
NCT04149522 is a clinical study titled "Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer". The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film...
What is the current status of trial NCT04149522?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-01-15. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT04149522?
The interventions under investigation include: Mepitel Film® (DEVICE).
Who is sponsoring clinical trial NCT04149522?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
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