Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas
CUSA-ENDO
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2025
CompletedFirst Submitted
Initial submission to the registry
October 1, 2025
CompletedFirst Posted
Study publicly available on registry
October 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
October 10, 2025
October 1, 2025
2.2 years
October 1, 2025
October 1, 2025
Conditions
Keywords
Outcome Measures
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.
Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery)
Secondary Outcomes (3)
Depth of tissue removal at different Tissue Select settings
Immediately after ex vivo treatment
Presence of residual endometriotic lesions at unscraped margins
Immediately after ex vivo treatment
Immunohistochemical assessment of epithelial and stromal markers
Within 1 week after sample fixation and processing
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 9208641, Japan
Related Publications (10)
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: 17094980BACKGROUNDD'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: 39477011BACKGROUNDFerrari 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: 40540997BACKGROUNDCandiani 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: 30299482BACKGROUNDYounis 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: 34265271BACKGROUNDMuzii 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: 25085800BACKGROUNDVasquez 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: 9050458BACKGROUNDAdamyan 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: 36175684BACKGROUNDMatsuzaki 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.
PMID: 19246468BACKGROUNDBafort 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.
PMID: 33095458BACKGROUND
Related Links
Biospecimen
Formalin-fixed, paraffin-embedded (FFPE) tissue specimens of ovarian endometrioma cyst walls obtained during surgery. Samples will be used for histopathological and immunohistochemical analyses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaoru Abiko, MD, PhD
Kanazawa University, Department of Obstetrics and Gynecology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 1, 2025
First Posted
October 10, 2025
Study Start
January 30, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share