Diagnostic Value of ICG in Endometriosi… | Clinical Trial

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Indocyanine Green (ICG) Laparoscopy Near Infrared Fluorescence Imaging Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

Indocyanine green is administered intra-venous after dilution with water in a peripheral vein at a dosage of 0.3mg/kg body weight as a bolus injection. The injection will take place during surgery. By using NIR fluorescence imaging ICG is made visible.

Primary outcomes

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

Time frame: 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

The number of histologically proven endometriotic lesions detected with NIR fluorescence imaging are compared to the number of lesions detected with white light laparoscopy alone and white light laparoscopy plus NIR fluorescence imaging.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 21, 2019
Registry last updated: Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed