Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

Recruiting

• Conditions: Ovarian Endometrioma; Endometriosis

• Registration Number: NCT07215130
• Lead Sponsor: Kanazawa University

Brief 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.

Detailed Description

Endometriomas are one of the most common manifestations of endometriosis and are frequently associated with infertility. Conventional cystectomy often results in inadvertent removal of normal ovarian tissue, which may reduce ovarian reserve. To address this issue, the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity system, particularly with the Tissue Select mode, has been proposed as a tissue-selective surgical device.

In this observational histopathological study, ovarian endometrioma wall specimens obtained during surgery are divided into multiple parts. Each part is subjected to ex vivo treatment with the CUSA Clarity device at different Tissue Select settings (0-4). The treated samples are fixed, paraffin-embedded, and stained with hematoxylin-eosin and immunohistochemical markers (e.g., cytokeratin 7, CD10). Pathologists evaluate the extent of removal of endometriotic lesions and preservation of normal ovarian stroma.

The primary objective is to assess whether endometriotic epithelium can be selectively removed while sparing ovarian stromal tissue. Secondary objectives include evaluation of the depth of tissue removal and the presence of residual lesions at unscraped margins. The results are expected to provide histopathological evidence supporting the potential clinical application of CUSA in fertility-preserving surgery for ovarian endometriomas.

Study Timeline

• Study Start: 2025-01-30
• Status Verified: 2025-10
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histopathological confirmation of selective removal of endometriotic epithelium with preservation of ovarian stroma	Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery)	Evaluation of hematoxylin-eosin and immunohistochemical stained sections to determine whether endometriotic epithelial lining is removed while normal ovarian stroma is preserved.

Secondary Outcome Measures

Name	Time	Method
Depth of tissue removal at different Tissue Select settings	Immediately after ex vivo treatment	Histological measurement of tissue removal depth under Tissue Select settings 0-4 using H\&E and Sirius Red staining.
Presence of residual endometriotic lesions at unscraped margins	Immediately after ex vivo treatment	Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity.
Immunohistochemical assessment of epithelial and stromal markers	Within 1 week after sample fixation and processing	Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal.

Trial Locations

Locations (1)

Kanazawa University Hospital; 🇯🇵 Kanazawa, Ishikawa-ken, Japan