Glowing dye could make endometriosis surgery safer for the ureters

NCT ID NCT05206279

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

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

Summary

This study tested whether injecting a fluorescent dye called indocyanine green (ICG) into the ureters helps surgeons see them more clearly during laparoscopic surgery for deep infiltrating endometriosis. 51 women with suspected or confirmed deep endometriosis took part. The goal was to see if this technique is feasible and could reduce the need for risky dissection of the ureters.

What this could mean

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

Active substance: Indocyanine Green (ICG) dye
What this could lead to: If successful, this technique could help surgeons avoid damaging the ureters during endometriosis surgery, reducing the need for risky dissection.
What could go wrong: This is a small, completed feasibility study with only 51 participants. The dye may not work for everyone, and it does not treat endometriosis itself.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

51 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2024

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.

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: * Informed Consent as documented by signature * Age 18 or older * Premenopausal status (menopause is defined as amenorrhea lasting one year or longer) * Proven (by laparoscopy or MRI) or highly suspected (ultrasound or clinically) deep infiltrating endometriosis Exclusion Criteria: * No DIE detectable intraoperatively * Known or suspected allergy to iodine, shellfish, or ICG dye * Hyperthyroid metabolic state (excluding treated hyperthyroidism with euthyroid metabolic state) * Severe renal insufficiency (GFR \< 30ml/min) * Simultaneous therapy with beta-blockers * Pregnant (positive human chorionic gonadotropin in the blood) or breastfeeding women * Intention to become pregnant during the course of the study * Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia) * Previous history of radiation therapy of the pelvis * Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery * Active, non treated urinary tract infection * Active pyelonephritis * Women having undergone surgery for reimplantation of the ureters (UCNS) or nephrostomy

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

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

Deep infiltrative endometriosis Icg (indocyanine green) Laparoscopy Near infrared imaging Visualization of ureters in gynecological surgery

Glowing dye could make endometriosis surgery safer for the ureters

What the study statuses mean