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New pelotte device aims to improve temperature accuracy in cancer heat therapy

NCT ID NCT07235540

Knowledge-focused Sponsor: Dr. G.H. (Henrike) Westerveld Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new device called a pelotte can measure vaginal temperature more accurately during deep hyperthermia (heat therapy) for gynecologic cancer. Twenty-seven women receiving radiation plus heat therapy will have their temperature measured with both the pelotte and a standard probe across multiple treatments. The goal is to see if the pelotte gives more consistent and reliable readings, which could help improve treatment precision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pelotte (a PTFE rod with a temperature catheter, covered by a condom)
What this could lead to
If successful, this could lead to more accurate temperature measurements during hyperthermia treatment, potentially improving treatment effectiveness for gynecologic cancer.
What could go wrong
This is a small, early-stage study (27 participants) focused on measurement accuracy, not treatment outcomes. The device may not improve clinical results or patient comfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

female reproductive organ cancer Hyperthermia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gynaecologic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, South Holand, 3015GD, Netherlands

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