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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06743256
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Having a BMI of at least 20 kg/m2
* Scheduled to undergo elective gynecological procedure
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
Exclusion Criteria:
* Individuals with BMI higher than 60 kg/m2.
* Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
* Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06743256
Study Brief:
Protocol Section:
NCT06743256