Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma (DUALENDO)

Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometriosis; Ovarian Endometrioma

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Giorgia Gaia; Phone Number: +393384406299; Email: giorgia.gaia@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm, including patients treated with cystectomy or adnexectomy, who consent to participation in this prospective pilot study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete histological ablation of endometriotic tissue	Histological absence of residual viable endometrial glands and stroma in ovarian endometrioma tissue following ex vivo ablation with the LEONARDO® DUAL 45 dual-wavelength diode laser.	Immediately after surgery, at histological examination of ex vivo surgical specimens.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension of laser-induced fibrosis/necrosis through the endometrioma pseudocapsule	Presence or absence of fibrosis and/or necrosis on the outer surface of the ovarian endometrioma pseudocapsule following ex vivo diode laser ablation.	Immediately after surgery, at histological examination of ex vivo surgical specimens.
Depth of thermal injury to healthy ovarian parenchyma	Depth of laser-induced thermal damage in the underlying healthy ovarian tissue, measured histologically in millimeters (mm) in specimens obtained from adnexectomy procedures.	Immediately after surgery, at histological examination of ex vivo surgical specimens.
Association between laser emission settings and histological tissue effects	Comparison of histological tissue effects induced by two diode laser emission settings (20 W, 980/1470 nm versus 15 W, 1470 nm), including necrosis depth and completeness of tissue ablation.	Immediately after surgery, at histological examination of ex vivo surgical specimens.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giorgia Gaia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): June 7, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 27370

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No