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NCT03088579 · ClinicalTrials.gov registry record
Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device
A clinical trial, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- 120
- Enrollment target
NCT03088579: Completed study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT03088579 is a clinical trial that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03088579 has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
Study Summary
The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT) loader (design patent pending). The reusable device will be made of surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers (HVL) to provide significant staff and user shielding as well as allowing it to be sterilized. It is utilized intraoperatively but off of the operative field and has no direct patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2 inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical Institute (BNI) operating rooms (OR).
Primary Outcome
Analyze users' (radiation oncologists and neurosurgeons) experience with the loader methodology by utilizing a standardized questionnaire recording 1) time added to case, 2) the size and size range of implants utilized, 3) conformality to operative bed, and 4) ease of use. Both perceptual (subjective) and numerical (objective) data will be obtained.
Interventions
- DEVICE GammaTile seed loader
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2013-04-02 |
| Est. Completion | 2020-08-11 |
What the finished NCT03088579 record still lists
NCT03088579 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which GammaTile seed loader is the first listed.
NCT03088579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03088579 about?
NCT03088579 is a clinical study titled "Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device". The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT...
What is the current status of trial NCT03088579?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2013-04-02. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT03088579?
The interventions under investigation include: GammaTile seed loader (DEVICE).
Who is sponsoring clinical trial NCT03088579?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
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