Clinical trial · Observational
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study
NCT07215130CI-TRIAL-00096487CUSA-ENDOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
| Ovarian Endometrioma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ovarian Endometrioma Cases
- description
- 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.
- interventionNames
- Device: Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity
Primary outcomes (1)
- measure
- Histopathological confirmation of selective removal of endometriotic epithelium with preservation of ovarian stroma
- timeFrame
- Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery)
- description
- Evaluation of hematoxylin-eosin and immunohistochemical stained sections to determine whether endometriotic epithelial lining is removed while normal ovarian stroma is preserved.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (10)
- RESULTMuzii 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
- RESULTD'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. PMID 39477011
- RESULTFerrari 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
- RESULTCandiani 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
- RESULTYounis 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
- RESULTMuzii 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.