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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT07274956
Eligibility Criteria:
Inclusion Criteria:Female, 18-55 years of age at time of surgery
Surgically treated for deep infiltrating endometriosis (DIE) with curative intent within the study period
Histopathologic confirmation of DIE on resected specimen (e.g., rectovaginal septum, uterosacral/cardinal ligaments, parametria, bowel, ureter, bladder, retrocervical/cervicovaginal sites)
Availability of archived FFPE tissue blocks adequate for H\&E and immunohistochemistry (e.g., SOX10) to quantify nerve fiber density
Documented preoperative pain assessment (e.g., VAS 0-10 for dysmenorrhea, dyspareunia, dyschezia, dysuria, and/or chronic pelvic pain) obtained within ≤3 months prior to index surgery
Accessible clinical data in the medical record (demographics, gynecologic history, prior medical/surgical therapies) sufficient for planned analyses
IRB approval in place; inclusion under written informed consent or IRB waiver applicable to retrospective data/tissue use -
Exclusion Criteria:No surgical resection of DIE (e.g., diagnostic laparoscopy only) or no histopathologic confirmation of DIE
Insufficient biospecimen (no/poor-quality FFPE tissue for H\&E/IHC)
Missing preoperative pain assessment (no VAS data within ≤3 months before index surgery)
Concomitant malignancy of the pelvis/abdominopelvic organs or malignancy treated within the past 5 years
Prior pelvic radiotherapy or major pelvic/nerve ablative surgery that precludes meaningful pain attribution
Acute pelvic infection at time of assessment or surgery (e.g., PID, tubo-ovarian abscess)
Primary pain disorders likely to confound attribution (e.g., interstitial cystitis/bladder pain syndrome, IBS with pain as dominant symptom, centrally mediated chronic pain syndromes) without adequate documentation to separate pain sources
\-
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07274956
Study Brief:
Protocol Section:
NCT07274956