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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT06119568
Eligibility Criteria:
Inclusion Criteria:
1. Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures.
2. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
3. Ability and willingness to comply with all study requirements to be evaluated for each study visit.
Exclusion Criteria:
1. Pregnant or breastfeeding women at the time of the surgery.
2. Subjects with severe concomitant illness that, at PI´s discretion, increases risk of therapeutic interventions or that have been submitted to multiple prior surgeries.
3. Subjects admitted to the hospital due to an emergency situation.
4. Subjects with untreated active infection.
5. Subject with known allergy to some of the device components (i.e., stainless steel, etc.)
6. Subjects not suitable to undergo MIS/MIRS, according to medical criteria.
7. Subjects with life expectancy inferior to 3 months.
8. Subjects with a BMI ≥ 40.
9. Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use.
10. Subjects with abuses of active substances or with uncontrolled psychiatric disorders.
11. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations.
12. Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system.
13. Inability to adhere to study-related procedures.
14. Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06119568
Study Brief:
Protocol Section:
NCT06119568