Recruiting

Fullyet

Sponsor:

Medical College of Wisconsin

Code:

NCT06820385

Conditions

Pelvic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Fullyet Device and CT Scans

Fullyet Device and MRI Scans

Study Details

Brief summary:

This is a device feasibility study to determine the feasibility of automatically predicting time to treatment readiness using a wearable imaging device (Fullyet) in both healthy volunteers and patients with pelvic malignancies undergoing radiation therapy.

Conditions

Pelvic Malignancies

Study ID

NCT06820385

Start date

May 2, 2025

Status verified date

Sep, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age ≥18 years.
2. Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment.
3. Patients (not healthy volunteers) can have any pelvic malignancy (e.g., rectal cancer, prostate cancer, bladder cancer, cervical cancer, anal cancer, endometrial cancer, sarcoma, bone metastatic lesions) being treated with radiation therapy.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol.
2. Inability to place device on skin (excessive hair or body habitus that is prohibitive).

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Healthy volunteers

Five healthy volunteers will be enrolled in this study.

experimental: Cancer patients

Ten cancer patients will be enrolled into this study.

Interventions

Fullyet Device and CT Scans

Cancer patients will wear the Fullyet Device. Real-time data will go to the patient and radiation therapy team. When the Fullyet Device indicates that the bladder is at optimal size, the radiation oncology team will get the patient. The patient will then have a CT scan.

Fullyet Device and MRI Scans

Healthy volunteers will first have an MRI scan. Then, they will wear the Fullyet Device. They will have up to two more MRIs to confirm bladder volume.

Primary outcome measure

  • The number of events showing feasibility [ Time Frame: Up to 2 months ]

Central Contacts and Locations

Central contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

866-680-0505cccto@mcw.edu

Locations

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kevin Rogacki, MD

414-805-4400krogacki@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Device feasibility study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-09-15.