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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian Endometrioma Cases | Patients with ovarian endometriomas undergoing surgical excision at Kanazawa University Hospital. Cyst wall specimens are collected and analyzed ex vivo using the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity device at different Tissue Select settings. Histopathological evaluation is performed to assess selective removal of endometriotic epithelium and preservation of ovarian stroma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after ex vivo treatment |
| Presence of residual endometriotic lesions at unscraped margins |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatsuhito Kanda, MD, PhD | Contact | +81-76-265-2425 | tkanda@staff.kanazawa-u.ac.jp | |
| Takashi Iizuka, MD, PhD | Contact | +81-76-265-2425 | zukatti@staff.kanazawa-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Kaoru Abiko, MD, PhD | Kanazawa University, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanazawa University Hospital | Recruiting | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17094980 | Result | Muzii L, Bianchi A, Bellati F, Cristi E, Pernice M, Zullo MA, Angioli R, Panici PB. Histologic analysis of endometriomas: what the surgeon needs to know. Fertil Steril. 2007 Feb;87(2):362-6. doi: 10.1016/j.fertnstert.2006.06.055. Epub 2006 Nov 13. | |
| 39477011 | Result | D'Alterio MN, Nappi L, Vitale SG, Agus M, Fanni D, Malzoni M, Falcone F, Sorrentino F, D'Agate MG, Scibilia G, Mereu L, Scollo P, Angioni S. Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser Ovarian Endometrioma Vaporization (OMAlaser): A Prospective, Single-Arm, Multicenter, Clinical Trial. J Minim Invasive Gynecol. 2025 Mar;32(3):279-287. doi: 10.1016/j.jmig.2024.10.021. Epub 2024 Oct 28. |
| Label | URL |
|---|---|
| Official website of the Department of Obstetrics and Gynecology, Kanazawa University | View source |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Formalin-fixed, paraffin-embedded (FFPE) tissue specimens of ovarian endometrioma cyst walls obtained during surgery. Samples will be used for histopathological and immunohistochemical analyses.
|
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Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity. |
| Immediately after ex vivo treatment |
| Immunohistochemical assessment of epithelial and stromal markers | Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal. | Within 1 week after sample fixation and processing |
| 40540997 | Result | Ferrari SM, Dolci C, Taccagni G, Congia C, Ottolina J, Schimberni M, Bartiromo L, Candiani M. Histologic findings from ablation of ovarian endometriomas using argon plasma coagulation (APC-ENDO): a pilot study. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114532. doi: 10.1016/j.ejogrb.2025.114532. Epub 2025 Jun 14. |
| 30299482 | Result | Candiani M, Ottolina J, Posadzka E, Ferrari S, Castellano LM, Tandoi I, Pagliardini L, Nocun A, Jach R. Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2205-2211. doi: 10.1093/humrep/dey305. |
| 34265271 | Result | Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13. |
| 25085800 | Result | Muzii L, Di Tucci C, Di Feliciantonio M, Marchetti C, Perniola G, Panici PB. The effect of surgery for endometrioma on ovarian reserve evaluated by antral follicle count: a systematic review and meta-analysis. Hum Reprod. 2014 Oct 10;29(10):2190-8. doi: 10.1093/humrep/deu199. Epub 2014 Aug 1. |
| 9050458 | Result | Vasquez JM, Eisenberg E, Osteen KG, Hickerson D, Diamond MP. Laparoscopic ablation of endometriosis using the cavitational ultrasonic surgical aspirator. J Am Assoc Gynecol Laparosc. 1993 Nov;1(1):36-42. doi: 10.1016/s1074-3804(05)80756-x. |
| 36175684 | Result | Adamyan L, Kasyan V, Pivazyan L, Isaeva S, Avetisyan J. Laser vaporization compared with other surgical techniques in women with ovarian endometrioma: a systematic review and meta-analysis. Arch Gynecol Obstet. 2023 Aug;308(2):413-425. doi: 10.1007/s00404-022-06799-4. Epub 2022 Sep 29. |
| 19246468 | Result | Matsuzaki S, Houlle C, Darcha C, Pouly JL, Mage G, Canis M. Analysis of risk factors for the removal of normal ovarian tissue during laparoscopic cystectomy for ovarian endometriosis. Hum Reprod. 2009 Jun;24(6):1402-6. doi: 10.1093/humrep/dep043. Epub 2009 Feb 26. |
| 33095458 | Result | Bafort C, Beebeejaun Y, Tomassetti C, Bosteels J, Duffy JM. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2020 Oct 23;10(10):CD011031. doi: 10.1002/14651858.CD011031.pub3. |
| D000091662 | Genital Diseases |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |