Prospective Evaluation of a Commercially Available Hydrogel Spacer

NCT ID: NCT05323747

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2022-02-08

Brief Summary

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Dosimetry efficacy evaluation of the hydrogel spacer

Detailed Description

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Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation with Hydrogel Spacer

Males at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place.

Observation

Intervention Type OTHER

Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.

Interventions

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Observation

Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males
* At lease 18 years of age
* Undergoing external beam or brachy radiation therapy with a hydrogel spacer

Exclusion Criteria

* Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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BioProtect

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Western Radiation Oncology

Campbell, California, United States

Site Status

Northern Nevada Radiation Oncology

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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BP-008

Identifier Type: -

Identifier Source: org_study_id

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