More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.
The Use of a Hyperthermia Pelotte to Acquire More Representative Vaginal Temperature Measurements During Deep Hyperthermia Treatments for Gynaecological Cancer; a Comparative Cross-over Study.
- Gynaecologic Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Dr. G.H. (Henrike) Westerveld
- Enrolment target
- 27
- Started
- 5 January 2026
- Main results due
- 5 January 2028
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Women aged 18 or older diagnosed with gynaecological cancer * Indication for EBRT with DHT * Written informed consent Exclusion Criteria: * Any condition potentially interfering with the understanding of the study requirements, informed consent procedure and completion of questionnaires * If the vaginal lumen is \<4 cm.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Erasmus MC
Rotterdam, South Holand, Netherlands
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07235540. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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