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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT05708651
Eligibility Criteria:
INCLUSION CRITERIA
Parts I-II:
Adult.
No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate).
Healthy with no medical comorbidity according to physician's judgement and physical examination.
No cognitive or psychosocial distress.
Complete or partial dentation.
No mobile teeth or reconstructions.
No orthodontic braces.
Non-pregnant.
Not breastfeeding.
Ability to communicate in Swedish.
No in situ magnetic device or implant \[II\].
Oral and written informed consent to inclusion as healthy volunteer study participant.
Parts III-IV:
Adult scheduled for elective colonoscopy \[III\] or ureteral catheterisation \[IV\] under procedural sedation with propofol.
No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate) in the ID.
Comorbidity ASA class I-III.
No cognitive or psychosocial distress.
Complete or partial dentation.
No mobile teeth or reconstructions.
No orthodontic braces.
Non-pregnant.
Not breastfeeding.
Ability to communicate in Swedish.
Oral and written informed consent to inclusion as study participant.
EXCLUSION CRITERIA
Parts I-IV:
Withdrawal of informed consent.
Suspected or manifest unforeseen allergic reaction.
Inability to obtain enough relevant study data for medical or technical reasons.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05708651
Study Brief:
Protocol Section:
NCT05708651