Completed

Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green

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What is being tested

Indocyanine Green

Drug
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Endometriosis

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: January 2017
See protocol details

Summary

Principal SponsorInsel Gruppe AG, University Hospital Bern
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2017

Actual date on which the first participant was enrolled.

Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.

Official TitleVisualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
NCT03850158
Principal SponsorInsel Gruppe AG, University Hospital Bern
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesEndometriosisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Informed Consent as documented by signature
Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
Patients should be in follicular phase
Have chronic pelvic pain and/or Infertility and be willing to undergo planned endometriosis resection procedure.
10 exclusion criteria prevent from participating
Known or suspected allergy to iodine, shellfish, or ICG dye
Hyperthyroidism
Severe renal insufficiency
Simultaneous therapy with beta-blockers
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
NIR fluorescence imaging is performed after white light laparoscopy. 0.3mg/kg bodyweight of ICG is administered i.v. All suspected lesions are removed and labeled whether they are seen in WL or NIR imaging or both. Evaluation is performed after the histological analysis of the lesions.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital

Bern, SwitzerlandOpen Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital in Google Maps
CompletedOne Study Center