Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity.
- Who it may be relevant to
- Registry conditions: Ovarian Endometrioma, Endometriosis. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study
Overview
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.
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- Depth of tissue removal at different Tissue Select settings [Time frame: Immediately after ex vivo treatment]
- Presence of residual endometriotic lesions at unscraped margins [Time frame: Immediately after ex vivo treatment]
- Immunohistochemical assessment of epithelial and stromal markers [Time frame: Within 1 week after sample fixation and processing]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Japan · 1 center
- Kanazawa University Hospital — Kanazawa
Publications
- 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. PMID 17094980
- 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. E PMID 39477011
- 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. PMID 40540997
- 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. PMID 30299482
- 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. PMID 34265271
- 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. PMID 25085800
- 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. PMID 9050458
- 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. PMID 36175684
Identifiers
NCT: NCT07215130 · KU-OBGYN-CUSA-2025-01