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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT03483194
Eligibility Criteria:
Inclusion Criteria:
1. Patient with malignant haematological pathology
2. Patient who must have an osteo-medullary biopsy for diagnostic purposes
3. Age ≥ 18 years
4. Performance Status \< 3
5. Patient with no pelvic bone pain before inclusion
6. Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count\> 50 G / L
7. Patient affiliated to the social security scheme
8. Patient giving written consent before any specific procedure related to the study
Exclusion Criteria:
1. Patient regularly taking antalgic treatments from stage 2 or 3
2. Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
3. Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension
4. Any contraindication to the use of the headset: pacemaker or other implanted medical device
5. Pregnancy or breastfeeding
6. Persons deprived of liberty, under guardianship or under guardianship
7. Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial
8. Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03483194
Study Brief:
Protocol Section:
NCT03483194