Cervical, vaginal and endometrial cancers Gynaecological cancer
Conditions
Interventions
The investigational product is a vaginal pelotte for DHT. The pelotte is a medical device. It is a round rod made of PTFE – polytetrafluoroethylene.
The top 7 cm has a diameter of 20 mm and the bottom
1. Not commercially available and no CE certification. 
 
2. Fiberglass probes do not fit into the catheters of this pelotte. 
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women aged 18 or older diagnosed with gynaecological cancer Indication for EBRT with DHT Written informed consent
Exclusion criteria
Exclusion criteria: Any condition potentially interfering with the understanding of the study requirements, informed consent procedure and completion of questionnairesIf the vaginal lumen is <4 cm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether the average vaginal temperature measured during DHT differs significantly between treatments performed with a pelotte and those with a standard vaginal probe. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 with a standard vaginal probe. | — |
Countries
Netherlands
Contacts
Public ContactA.F. Rink
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed