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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 is a clinical trial that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 120 participants.

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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).

Interventions

  • DEVICE GammaTile seed loader

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2013-04-02
Est. Completion 2020-08-11

What the Registry Record Tells You About NCT03088579

The ClinicalTrials.gov registry entry for NCT03088579 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which GammaTile seed loader is the first listed.

NCT03088579 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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