CompletedEarly Phase 1

Diagnostic Value of ICG in Endometriosis

Switzerland63 participantsStarted 2017-01

Plain-language summary

This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Known or suspected allergy to iodine, shellfish, or ICG dye * Hyperthyroidism * Severe renal insufficiency * Simultaneous therapy with beta-blockers * Women who are pregnant (positive HCG in the blood) or breast feeding * 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) * Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated markers of infection in the blood) * Previous history of radiation therapy of the pelvis * Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy

Timeframe: The duration of the participation is from the signature of the informed consent until the end of the hospitalisation, expected to be on average after 2 to 4 days

Trial details

NCT IDNCT03850158

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11

View on ClinicalTrials.gov More Endometriosis trials