RecruitingNCT07215130

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study

Sponsor

Kanazawa University

Enrollment

10 participants

Start Date

Jan 30, 2025

Study Type

OBSERVATIONAL

Conditions

Endometriosis Ovarian Endometrioma

Summary

This study aims to evaluate the feasibility and tissue selectivity of a novel surgical technology, the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity, in the management of ovarian endometriomas. Ovarian endometriomas are cysts caused by endometriosis that can damage ovarian reserve when treated by conventional surgery. In this study, ovarian cyst wall specimens are examined ex vivo using different Tissue Select settings of the CUSA device. Histopathological analyses are performed to determine whether endometriotic epithelium can be selectively removed while preserving normal ovarian tissue. The findings may contribute to developing fertility-preserving surgical approaches for women with endometriomas.

Eligibility

Sex: FEMALEMin Age: 20 Years

Inclusion Criteria4

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 Criteria2

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.

Interventions

DEVICECavitron Ultrasonic Surgical Aspirator (CUSA) Clarity

Ex vivo application of the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity device to ovarian endometrioma cyst wall specimens. Tissue Select settings from 0 to 4 are used to evaluate tissue selectivity, specifically removal of endometriotic epithelium while preserving normal ovarian stroma. Samples are subsequently analyzed histopathologically.