Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma

NCT07635199 | Not Yet Recruiting

• 1 other identifier: 27370
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Endometrioma; Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Extension of laser-induced fibrosis/necrosis through the endometrioma pseudocapsule

  Immediately after surgery, at histological examination of ex vivo surgical specimens.

• Depth of thermal injury to healthy ovarian parenchyma

  Immediately after surgery, at histological examination of ex vivo surgical specimens.

• Association between laser emission settings and histological tissue effects

  Immediately after surgery, at histological examination of ex vivo surgical specimens.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giorgia Gaia

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgia Gaia

CONTACT

+393384406299; giorgia.gaia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 7, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06