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Laser zaps endometriosis cysts: could this spare fertility?

NCT ID NCT07635199

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study investigates how well a dual-wavelength diode laser can destroy endometriotic tissue inside ovarian cysts (endometriomas). Researchers will apply the laser to cyst walls removed during surgery and examine the tissue under a microscope to see if all abnormal cells are killed and how deeply the laser penetrates. The goal is to gather data that could lead to a surgical technique that preserves ovarian function better than current methods. About 30 women having laparoscopic surgery for ovarian endometriomas will provide tissue samples for this ex vivo analysis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dual-wavelength diode laser (LEONARDO® DUAL 45)
What this could lead to
If successful, this could help refine laser settings for ovarian endometrioma surgery, potentially preserving fertility better than standard cyst removal.
What could go wrong
This is a small pilot study on surgically removed tissue, not a treatment trial. Results may not translate to live surgery or improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endometriosis ovarian endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis Ovarian endometrioma

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.