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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT05104268
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic chemotherapy-induced oral mucositis
* Need for oral topical therapy for symptomatic treatment
* Absence of other chronic oral disorders
* Properly obtained written informed consent
* Age of 18 years or older
* Patient is willing to use the Bocaliner™ device for 2 weeks
* No concurrent use of medications modulating pain
Exclusion Criteria:
* Chronic oral conditions other than chemotherapy-induced oral mucositis
* No informed consent
* Age of \<18
* Inability to place the device in his/her mouth and keep it in place for at least 10 minutes due to severe oral pain, large lesions, or any other reason
* Inability/unwillingness to wear Bocaliner™ for the study period
* Concurrent use of pain-modulating agents
* Individuals with known allergies to silicone materials
* Individuals with severe difficulties to communicate and understand
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05104268
Study Brief:
Protocol Section:
NCT05104268