Clinical Trial

More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.

Study acronym: ORIENTATE
Not Yet Recruiting
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Summary
The goal of this comparative, cross over single centre study is to to determine whether the average measured vaginal temperature during hyperthermia treatment is (clinically) significant different with the use of a pelotte than with a standard vaginal probe. in 27 women treated with external beam radiotherapy and deep hyperthermie for gynaecological cancer.. The primary endpoint is measured average vaginal temperatures with pelotte versus a standard vaginal probe. The secondary endpoints are: reproducibility of catheter placement, patient comfort, inter-fractional spread of the vaginal temperature and the average vaginal temperature at the tip (0 cm) and 2 cm from the tip with pelotte and a standard vaginal probe. Participants will be treated at least two time with a pelotte and two times with a standard vaginal probe. Participants will be asked to fill in a short questionnaire three times per treatment (before, during and after treatment). A total of 12-15 questionnaires will be completed by the participants over the four to five treatments.
Trial Details
NCT Number NCT07235540
Lead Sponsor Dr. G.H. (Henrike) Westerveld
Conditions Gynaecologic Cancer
Enrollment 27 participants
Start Date 2026-01-05
Primary Completion 2028-01-05 (estimated)
Study Completion 2028-01-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-19