Ovarian EndometriomaDUALENDONCT07635199
Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma
An observational study of Ovarian Endometrioma and Endometriosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Endometrioma, Endometriosis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2026to 30 Dec 2027
- How long will I take part?
- 6 Months
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery, at histological examination of ex vivo surgical specimens.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately after surgery, at histological examination of ex vivo surgical specimens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start7 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Gaia, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635199
- Sponsor's protocol ID
- 27370
- Acronym
- DUALENDO
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study
- ClinicalTrials.gov ID
- NCT07635199
- Acronym / sponsor ID
- DUALENDO / 27370
- Conditions
- Ovarian Endometrioma, Endometriosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete histological ablation of endometriotic tissue
Time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for Ovarian Endometrioma
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
RecruitingObservational study
Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
Endometriosis
Not yet recruitingObservational study
Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas
Endometriosis, Endometrioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giorgia Gaia principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Endometrioma and Endometriosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Giorgia Gaia (+393384406299, giorgia.gaia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete histological ablation of endometriotic tissue (time frame: Immediately after surgery, at histological examination of ex vivo surgical specimens.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.