Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Endometrioma, Endometriosis. Basic parameters: from 18 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study
Overview
Background: Ovarian endometrioma is the most common manifestation of endometriosis and is associated with chronic pelvic pain, infertility, and reduced ovarian reserve. Surgical treatment options include cystectomy and ablative techniques. Recent evidence suggests that ablative approaches may better preserve ovarian reserve compared with cystectomy while maintaining comparable recurrence and pregnancy rates. However, limited histological data are available regarding the depth of tissue damage induced by ablative techniques and their ability to completely eradicate endometriotic tissue. Objective: This pilot study aims to histologically evaluate the effects of ex vivo ovarian endometrioma ablation using the LEONARDO® DUAL 45 dual-wavelength diode laser (980 nm and 1470 nm). The study will assess the completeness of endometriotic tissue ablation, the depth of laser-induced necrosis within the endometrioma pseudocapsule, and the extent of thermal injury to the surrounding ovarian tissue. Methods: Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm will be prospectively enrolled. Surgical treatment will consist of cystectomy in reproductive-age women and adnexectomy in selected peri- or postmenopausal women according to routine clinical practice. After surgical excision, ex vivo samples of the internal endometrioma wall will undergo laser ablation using two different laser settings. Histological examination will evaluate residual endometrial glands and stroma, depth of necrosis, and thermal damage to adjacent ovarian tissue. Clinical, surgical, and pathological data will also be collected. Study Design: Prospective, observational, pilot study involving a medical device. Approximately 30 patients will be enrolled, generating multiple histological specimens for analysis. The study is designed to provide preliminary evidence regarding the histological efficacy and tissue effects of dual-wavelength diode laser ablation of ovarian endometriomas.
Primary outcome measures
- Complete histological ablation of endometriotic tissue [Time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.]
Secondary outcome measures (3)
- Extension of laser-induced fibrosis/necrosis through the endometrioma pseudocapsule [Time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.]
- Depth of thermal injury to healthy ovarian parenchyma [Time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.]
- Association between laser emission settings and histological tissue effects [Time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.]
Eligibility criteria
Inclusion criteria
- Female participants aged 18 years or older
- Ultrasound diagnosis of at least one unilateral or bilateral ovarian endometrioma measuring ≥3 cm in maximum diameter
- Scheduled for laparoscopic surgery (cystectomy or adnexectomy)
- Ability and willingness to provide written informed consent.
Exclusion criteria
- Suspected ovarian malignancy based on preoperative clinical or imaging evaluation
- Presence of concomitant pelvic disease requiring complex surgical management or potentially interfering with histological assessment (e.g., pelvic inflammatory disease)
- Medical conditions contraindicating laparoscopic surgery
- Inability or unwillingness to provide written informed consent
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
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07635199 · 27370