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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT07074067
Eligibility Criteria:
Inclusion Criteria:
* Age of majority (\> 18 years)
* Willingness to participate in the study and signing of informed consent
* Histological diagnosis, by endometrial biopsy (either using a Cornier cannula or directed by diagnostic hysteroscopy) of atypical endometrial hyperplasia or low-grade endometrioid adenocarcinoma (G1-G2), with an initial stage (IA) at preoperative evaluation
Exclusion Criteria:
Pregnant Women
* Nullicottitis
* Severe uterine prolapse (grade IV)
* Large myomatous uterus (greater than 18 weeks of gestation)
* Severe comorbidities that contraindicate surgery, such as sepsis, severe renal failure, severe cardiopulmonary disease, or severe coagulopathies 33
* Presence of previous illnesses or treatments that may have caused severe pelvic adhesions that obliterate the Douglas pouch and prevent vaginal entry, such as deep pelvic endometriosis, severe pelvic inflammatory disease, inflammatory bowel disease (ulcerative colitis, diverticulitis, Crohn's disease), or a history of pelvic radiotherapy, among others
* Concomitant presence of adnexal masses or formations of considerable size that are expected to substantially lengthen the uterus Surgical time due to the difficulty of extraction
* Contraindication to general anesthesia
* Active pelvic or lower urinary tract infection
* Clinical suspicion of advanced stage of the neoplasia
* Any histological type of endometrial cancer other than those described previously.
* High histological grade (G3)
* Current abnormality in cervical cytology (CVC) requiring more aggressive surgical intervention
* Revocation of informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07074067
Study Brief:
Protocol Section:
NCT07074067