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NCT Number: NCT07215130

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 9208641, Japan

Location status: Recruiting

Location contact

Tatsuhito Kanda, MD, PhD

CONTACT

[email protected]

+81-76-265-2000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity

Device

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.

Other names: CUSA Clarity

Primary outcomes

  1. Histopathological confirmation of selective removal of endometriotic epithelium with preservation of ovarian stroma

    Time frame: 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 outcomes

  1. Depth of tissue removal at different Tissue Select settings

    Time frame: Immediately after ex vivo treatment

    Histological measurement of tissue removal depth under Tissue Select settings 0-4 using H&E and Sirius Red staining.

  2. Presence of residual endometriotic lesions at unscraped margins

    Time frame: Immediately after ex vivo treatment

    Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity.

  3. Immunohistochemical assessment of epithelial and stromal markers

    Time frame: Within 1 week after sample fixation and processing

    Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal.

Study contacts

Contact information is provided by the study sponsor or research team.

Takashi Iizuka, MD, PhD

CONTACT

[email protected]

+81-76-265-2425

Tatsuhito Kanda, MD, PhD

CONTACT

[email protected]

+81-76-265-2425

Sponsors and collaborators

Lead sponsor

Kanazawa University

Other

Registry information

Official study title

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

Acronym: CUSA-ENDO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 10, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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