Histologic analysis of endometriomas: what the surgeon needs to know.
Ludovico Muzii, Antonella Bianchi, Filippo Bellati...
https://pubmed.ncbi.nlm.nih.gov/17094980Actively Recruiting
Age: 20Years +
FEMALE
ID07215130
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas: A Case-Based Histopathological Study
Led by Kanazawa University · Updated on 2025-10-10
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian endometriomas are cysts caused by endometriosis that can harm ovarian reserve when treated with conventional surgery. This research evaluates the feasibility and tissue selectivity of a new surgical device called the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity in managing these cysts. The study aims to determine if this device can selectively remove endometriotic lesions while preserving normal ovarian tissue, potentially supporting fertility-preserving surgical methods for women with ovarian endometriomas. The study observes ovarian cyst wall specimens collected during surgery from patients with ovarian endometriomas. These specimens are treated outside the body using the CUSA Clarity device at various Tissue Select settings ranging from 0 to 4. After treatment, samples undergo detailed histopathological and immunohistochemical analyses to assess how well the device removes diseased tissue and preserves healthy ovarian stroma. This approach helps evaluate the device's tissue selectivity without performing the procedure directly on patients. Participants are women aged 20 years or older undergoing surgical removal of ovarian endometriomas. After surgery, their cyst wall specimens are collected for ex vivo treatment and analysis. Researchers examine tissue samples immediately after treatment and within one week for markers indicating selective removal of endometriotic epithelium and preservation of normal ovarian tissue. The study includes histopathological confirmation, depth of tissue removal, and presence of residual lesions, with results expected to inform future fertility-friendly surgical techniques.
CONDITIONS
Brief Title
Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas
Who Can Participate
Age: 20Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients diagnosed with ovarian endometrioma undergoing surgical treatment (cystectomy or adnexectomy) at Kanazawa University Hospital between January 1, 2025, and March 31, 2027
- Written informed consent obtained before participation
- Age 20 years or older at time of consent
- Additional written consent for patients with previously stored endometrioma specimens under broad consent
You will not qualify if you...
- Patients with suspected malignancy based on preoperative imaging
- Patients judged unsuitable for participation by the attending physician for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo surgical excision of ovarian endometriomas to collect cyst wall specimens.
1 visit (in-person)
Implementation
Duration - Within 1 day of surgery
Ex vivo application of the Cavitron Ultrasonic Surgical Aspirator (CUSA) Clarity device to ovarian endometrioma cyst wall specimens at different Tissue Select settings for histopathological evaluation.
Specimen processing performed without additional participant visits
Diagnostic Evaluation
Duration - Within 1 week after sample fixation and processing
Histopathological and immunohistochemical assessment of treated specimens to evaluate selective removal of endometriotic epithelium and preservation of ovarian stroma.
No participant visits required
Trial Site Locations
Total: 1 location
1
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 9208641
Actively Recruiting
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Research Team
T
Tatsuhito Kanda, MD, PhD
T
Takashi Iizuka, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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