Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 9208641, Japan
Location status: Recruiting
NCT Number: NCT07215130
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.
Interested in participating?
Request Info20 year and older
Female
Observational
Kanazawa, Ishikawa-ken, 9208641, Japan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: Immediately after ex vivo treatment
Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity.
Time frame: Within 1 week after sample fixation and processing
Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal.
Contact information is provided by the study sponsor or research team.
Takashi Iizuka, MD, PhD
CONTACT
Tatsuhito Kanda, MD, PhD
CONTACT
Kanazawa University
Other
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study
Acronym: CUSA-ENDO
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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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