Selective removal of endometriotic lining from ovarian endometriomas using CUSA Clarity
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study
This project will try the CUSA Clarity device on tissue from women with ovarian endometriomas to see if it removes endometriotic lining while preserving healthy ovarian tissue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Kanazawa University Academic / other |
| Locations | 1 site (Kanazawa, Ishikawa-ken) |
| Trial ID | NCT07215130 on ClinicalTrials.gov |
What this trial studies
In this observational ex vivo histopathology study, ovarian endometrioma wall specimens obtained during surgery are divided and treated with the CUSA Clarity ultrasonic aspirator using Tissue Select settings 0–4. Treated samples are fixed, paraffin-embedded, and stained with hematoxylin-eosin plus immunohistochemical markers (for example, cytokeratin 7 and CD10). Pathologists evaluate the extent of removal of endometriotic epithelium, preservation of ovarian stroma, depth of tissue removal, and presence of residual lesions at margins. The findings are intended to inform whether CUSA Clarity could be adapted for fertility-preserving surgical approaches to ovarian endometriomas.
Who should consider this trial
Good fit: Women aged 20 or older undergoing surgical treatment for ovarian endometrioma at Kanazawa University Hospital who provide written informed consent between January 1, 2025 and March 31, 2027 are eligible.
Not a fit: Patients with suspected malignancy on preoperative imaging, those not undergoing surgical removal of an endometrioma, or those who do not consent are unlikely to receive benefit from this ex vivo tissue study.
Why it matters
Potential benefit: If successful, this approach could allow removal of endometriotic tissue while preserving ovarian reserve and improving fertility prospects.
How similar studies have performed: Ultrasonic aspirators like CUSA have demonstrated tissue-selective effects in other surgical settings, but applying CUSA Clarity specifically to selectively remove endometriotic epithelium ex vivo is a novel and relatively untested application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients diagnosed with ovarian endometrioma who undergo surgical treatment (cystectomy or adnexectomy) at Kanazawa University Hospital between January 1, 2025, and March 31, 2027. * Written informed consent obtained prior to study participation. * Age ≥ 20 years at the time of consent. * For patients with previously stored endometrioma specimens under a broad consent, additional written consent for participation in this study will be obtained. Exclusion Criteria: * Patients with suspected malignancy based on preoperative imaging. * Patients judged by the attending physician to be unsuitable for participation in this study for any reason.
Where this trial is running
Kanazawa, Ishikawa-ken
- Kanazawa University Hospital — Kanazawa, Ishikawa-ken, Japan (Recruiting)
Study contacts
- Principal investigator: Kaoru Abiko, MD, PhD — Kanazawa University, Department of Obstetrics and Gynecology
- Study coordinator: Tatsuhito Kanda, MD, PhD
- Email: tkanda@staff.kanazawa-u.ac.jp
- Phone: +81-76-265-2425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.