Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Histopathological confirmation of selective removal of endometriotic epithelium with preservation of ovarian stroma [Срок оценки: Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery)]

Вторичные конечные точки (3)

• Depth of tissue removal at different Tissue Select settings [Срок оценки: Immediately after ex vivo treatment]
• Presence of residual endometriotic lesions at unscraped margins [Срок оценки: Immediately after ex vivo treatment]
• Immunohistochemical assessment of epithelial and stromal markers [Срок оценки: Within 1 week after sample fixation and processing]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Япония · 1 центр

• Kanazawa University Hospital — Kanazawa

Публикации

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Идентификаторы

NCT: NCT07215130 · KU-OBGYN-CUSA-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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