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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00989820
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Age ≥ 18 jr
* WHO performance status 0-2
* Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.
* Local recurrence must be ruled out
* Necrosis of the jaw with at least one of the following symptoms for over 3 month present:
* Bone exposition which measures at least 1 cm
* Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
* Non-healing extraction socket
Exclusion Criteria:
* Former HBO treatment
* Contra indication for HBO treatment (pneumothorax)
* Bisphosphonate treatment in the medical history
* reirradiation in the medical history
* Osteosynthesis material in the affected area
* Distant metastasis
* Primary or recurrent tumor in the affected area
* Malignancies elsewhere
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00989820
Study Brief:
Protocol Section:
NCT00989820