Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorKanazawa University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Women aged 20 years or older diagnosed with ovarian endometrioma and treated surgically at Kanazawa University Hospital. Surgically resected ovarian endometrioma specimens are used for ex vivo histopathological evaluation of selective lesion removal using the CUSA® Clarity device.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity
DeviceEx 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Ovarian Endometrioma Cases1 intervention
Trial outcomes
Primary outcomes
1
Histopathological confirmation of selective removal of endometriotic epithelium with preservation of ovarian stroma
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 CUSA treatment of specimens (within 1 day of surgery)Secondary outcomes
1
Depth of tissue removal at different Tissue Select settings
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 treatment2
Presence of residual endometriotic lesions at unscraped margins
Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity.
Time frame
Immediately after ex vivo treatment3
Immunohistochemical assessment of epithelial and stromal markers
Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal.
Time frame
Within 1 week after sample fixation and processingSponsors and contacts
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Source ClinicalTrials.gov