Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT03755895
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ≥ 18 and ≤ 80 years
* Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:
* Deep interstitial application: anal canal, vagina, vulva
* Gynecological application: mold, Utrecht® system or Venezia® system
* Ability to provide written informed consent
* Patients affiliated to the social security system
Exclusion Criteria:
* Minor and patients over 80 years old
* Patients with major hearing loss
* Patients who had recent ocular surgery with oculiare gas injection.
* Patients suffering from psychotic disorders, and dementias.
* Patients who do not understand the French language
* Patients under guardianship or deprived of liberty
* Patients with a contraindication to the administration of KALINOX®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03755895
Study Brief:
Protocol Section:
NCT03755895