Wearable AI Device to Guide Daily Pelvic Radiation Timing
Official title: Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
Run by Medical College of Wisconsin · NCT06820385 · Data updated 2026-11-12
A wearable ultrasound device tests whether it can reliably predict when the bladder is full to time pelvic radiation therapy for patients and healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | May 2, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT06820385 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with any pelvic malignancy receiving radiation therapy, who can drink water to fill a bladder and consent to participation.
✕Probably not a fit
Patients unlikely to benefit include those unable to use the device due to skin access limitations or ultrasound gel intolerance, or those not undergoing pelvic radiotherapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study evaluates an experimental wearable, Fullyet, that uses ultrasound to estimate bladder fullness to optimize the timing of pelvic radiation therapy. The aim is to reduce treatment delays and unnecessary CT scans by predicting readiness for each daily session. The study compares CT- and MRI-based assessments with the wearable device to determine accuracy and practicality in real-world settings. It includes adults with pelvic malignancies undergoing radiation and healthy volunteers, and it measures feasibility, safety, and potential workflow benefits. Interventions involve the Fullyet device alongside standard imaging during treatment planning and delivery.
Why it matters
Potential benefit: If successful, patients may experience fewer treatment delays and reduced unnecessary imaging, leading to less stress and lower radiation exposure.
How similar studies have gone: Previous work in image-guided radiotherapy has explored bladder-based timing, with some feasibility data supporting the concept; this study tests a novel wearable approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Kevin Rogacki, MD — Medical College of Wisconsin
- Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Email: cccto@mcw.edu
- Phone: 866-680-0505
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.