An interventional study of Pelotte in Gynaecologic Cancer, sponsored by Dr. G.H. (Henrike) Westerveld. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Dr. G.H. (Henrike) Westerveld · Not applicable, Interventional, and Other
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.
256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.
This study's planned enrollment of 27 is below the median of 40 across 232 interventional studies indexed under Hyperthermia.
Browse Hyperthermia studies →This is the only study on the registry with Dr. G.H. (Henrike) Westerveld as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be treated with a pelotte in treatment 1,3 and 5
Device: Pelotte
Participants will be treated with a pelotte in treatment 1,2 and 4
Device: Pelotte
The pelotte is a medical device. It is a round rod made of PTFE - polytetrafluoroethylene (figure 3). The top 7 cm has a diameter of 20 mm and the bottom 13 cm has a diameter of 11 mm. One disposable catheter for temperature measurements will be attached to the pelotte with tape. This catheter will be placed ventrally on the pelotte. A thermometer will be placed in this catheter. This thermometer will measure the vaginal temperatures. A condom is then placed over the pelotte and the catheter before insertion into the patient. At least two treatment will be with pelotte and at least 2 with a standard vaginal probe.
• Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.
To compare if the average vaginal measured temperature is significant different with a pelotte versus the standard vaginal probe
Time frame: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration
Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe.
For each treatment, the free length of the vaginal probe is measured from the outer labia to the probe tip. This distance is subtracted from 293 mm to determine the internal depth of the vaginal probe. In the control room, the depth is determined based on the temperature measurements. If the measured temperature falls below 36 degrees Celsius at a certain point (e.g., 8 cm from the tip), this point is considered the probe depth. These values are then compared to assess whether there is a difference in reproducibility between treatments using the pelotte and treatments using only a vaginal probe.
Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration
Inter-fractional variance in measured vaginal temperatures with pelotte and with a standard vaginal probe.
Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.
Patient-reported comfort with pelotte and with a standard vaginal probe, as assessed using the 'Vragenlijst Hyperthermie Pelotte' questionnaire
Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.
Average vaginal temperature at the measurement points of the tip (0 cm) and two cm from the tip of the catheter with pelotte and with a standard vaginal probe.
Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
Of 103 non-industry interventional studies with no phase under Hyperthermia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 24 months is above that.
Counting every sponsor, half of 108 studies reached it within 18 months; a quarter within 7 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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