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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05414760
Eligibility Criteria:
Inclusion Criteria:
* Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
* Women 30 years old or older;
* Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
* Subjects who can comply with the study follow-up and other study requirements.
Exclusion Criteria:
* Cavity length \<4 or \>8
* Perforation during ablation procedure
* Previous adhesiolysis procedure or diagnosis of Asherman's disease.
* Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
* History of cervical or endometrial cancer
* Active pelvic infection or history of pelvic peritonitis
* Known contraindication or hypersensitivity to Womed Leaf component
* Current participation in another clinical investigation that has not yet received the primary endpoint
* Any other condition that makes participation in the study contrary to the patient's best interests.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT05414760
Study Brief:
Protocol Section:
NCT05414760