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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT07273916
Eligibility Criteria:
Inclusion Criteria:
1. Age above 18 years.
2. Willingness and ability to undergo the procedures described in the protocol.
3. Candidates who understand and sign the Informed Consent Form (ICF) upon study entry, prior to any study-related procedures.
Exclusion Criteria:
1. Pregnant or breastfeeding on the day of the study.
2. History of sensitivity to topical anesthetics or any component of the anesthetic marker formulation.
3. Symptoms of infection at the application site.
4. Eczema or skin alterations at the application site.
5. Any other active inflammations or infections in the treated areas.
6. Any surgical procedure performed that may have affected the area to be assessed in this study.
7. Severe psychiatric disorders.
8. Any other uncontrolled chronic or serious medical condition which, in the investigator's opinion, may interfere with the interpretation of the clinical study results or place the participant at significant risk.
9. Use of analgesic medications.
10. Vulnerable groups (such as individuals deprived of liberty) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines.
11. Participation in any other clinical drug or device study and/or participation within 7 days prior to Day 1 of this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07273916
Study Brief:
Protocol Section:
NCT07273916