Gynaecologic CancerORIENTATENCT07235540
More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.
A study testing Pelotte in people with Gynaecologic Cancer, run by Dr. G.H. (Henrike) Westerveld at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecologic Cancer
- What is being tested?
- Pelotte
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2026to 5 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 or older diagnosed with gynaecological cancer
- Indication for EBRT with DHT
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holand, 3015GD
About this study
Official title: 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.
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.
- Conditions
- Gynaecologic Cancer
- Being tested
- Pelotte
- Keywords
- Pelotte, Hyperthermia, Probe, Gynaecologic
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelotteDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Participants will be treated with a pelotte in treatment 1,3 and 5 Receives: Device: Pelotte |
| Group 2 | Other | Participants will be treated with a pelotte in treatment 1,2 and 4 Receives: Device: Pelotte |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start5 Jan 2026
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants will be treated at least two treatments with pelotte and at least two with a standard vaginal probe. Based on a sample size calculation, 27 participants need to be included to achieve sufficient statistical power. Additionally, these data will be used to complete the MDR procedure for the pelotte (clinical validation).
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. G.H. (Henrike) Westerveld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. G.H. (Henrike) Westerveld, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235540
- Sponsor's protocol ID
- NL-010698
- Acronym
- ORIENTATE
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07235540
- Acronym / sponsor ID
- ORIENTATE / NL-010698
- Conditions
- Gynaecologic Cancer
- Keywords
- Pelotte, Hyperthermia, Probe, Gynaecologic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Dr. G.H. (Henrike) WesterveldUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 5 Jan 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be treated at least two treatments with pelotte and at least two with a standard vaginal probe. Based on a sample size calculation, 27 participants need to be included to achieve sufficient statistical power. Additionally, these data will be used to complete the MDR procedure for the pelotte (clinical validation).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: PelotteParticipants will be treated with a pelotte in treatment 1,3 and 5 |
| Group 2 | Other | Device: PelotteParticipants will be treated with a pelotte in treatment 1,2 and 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 or older diagnosed with gynaecological cancer
- Indication for EBRT with DHT
- Written informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelotteThe 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. | Device | Group 1, Group 2 |
Primary outcome
• Average vaginal temperature during DHT treatments 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
To compare if the average vaginal measured temperature is significant different with a pelotte versus the standard vaginal probe
4 secondary outcomes
Inter-fractional reproducibility of the catheter placement in depth and position 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelotte in people with Gynaecologic Cancer, run by Dr. G.H. (Henrike) Westerveld at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact G.H Westerveld, Dr. (+31107041249, g.westerveld@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Average vaginal temperature during DHT treatments 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.