Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecologic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelotte | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1
- description
- Participants will be treated with a pelotte in treatment 1,3 and 5
- interventionNames
- Device: Pelotte
- type
- OTHER
- label
- Group 2
- description
- Participants will be treated with a pelotte in treatment 1,2 and 4
- interventionNames
- Device: Pelotte
Primary outcomes (1)
- measure
- • Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.
- timeFrame
- approximately seven weeks from the intake with the radiation oncologist to the last treatment administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available