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Recruiting Observational

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

NCT07215130 · tracked via the Priya Life Science Japan tracker
Sponsor
Kanazawa University
Phase
Observational
Started
2025-01-30
Last updated
2025-10-10

Condition(s) studied

Ovarian EndometriomaEndometriosis

Investigational drug(s) / intervention(s)

Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity

Cavitron 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.

Study 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
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Kanazawa University Hospital Kanazawa Ishikawa-ken Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215130 on ClinicalTrials.gov ↗ ← All trials in Japan