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Ovarian EndometriomaCUSA-ENDONCT07215130

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas

An observational study of Ovarian Endometrioma and Endometriosis, run by Kanazawa University at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Ovarian Endometrioma, Endometriosis
What is being tested?
Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity
Type of treatment
Medical device
How many people
10 participants
Where
1 siteJapan
Study dates
30 Jan 2025to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Japan1 site, 1 recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 9208641

    Tatsuhito Kanda, MD, PhD, +81-76-265-2000, tkanda@staff.kanazawa-u.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study

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.

Read the 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.

Being tested
Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity
Keywords
Endometriosis, Ovarian Cyst, CUSA Clarity, Ultrasonic Surgical Aspirator, Fertility Preservation, Histopathology
Medical subject headings
Endometriosis, Ovarian Cysts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cavitron Ultrasonic Surgical Aspirator (CUSA) ClarityDevice

    Also called 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.

Study groups in NCT07215130
Study groupRoleWhat they receive
Ovarian Endometrioma CasesPatients 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.
Receives: Device: Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after ex vivo CUSA treatment of specimens (within 1 day of surgery)

Secondary outcomes (3)

  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.

    Measured: Immediately after ex vivo treatment

  2. Presence of residual endometriotic lesions at unscraped margins

    Histological evaluation of cyst wall margins not subjected to CUSA scraping to confirm lesion selectivity.

    Measured: Immediately after ex vivo treatment

  3. Immunohistochemical assessment of epithelial and stromal markers

    Immunostaining with cytokeratin 7 (epithelial) and CD10 (stromal) to assess selective tissue removal.

    Measured: Within 1 week after sample fixation and processing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start30 Jan 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215130
Sponsor's protocol ID
KU-OBGYN-CUSA-2025-01
Acronym
CUSA-ENDO
Status last verified
Oct 2025
First submitted
1 Oct 2025
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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. Epub 2024 Oct 28.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36175684

  • 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.

    PubMed 19246468

  • 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.

    PubMed 33095458

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Endometrioma and Endometriosis, run by Kanazawa University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tatsuhito Kanda, MD, PhD (+81-76-265-2425, tkanda@staff.kanazawa-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215130, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.

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