The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis

The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis - Fluorescence Imaging for Intraoperative Detection of Endometriosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47083

Enrollment

Registered

2016-12-14

Start date

2017-01-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected or proven Able to understand the nature of the study and what will be required of them Females Age >18years Premenopausal No history of impaired liver and renal function No history of hypersensitivity or allergy to indocyanine green Willing to participate

Exclusion criteria

Exclusion criteria: Not able to give written informed consent Males Aged

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: Investigate the feasibility of identification of endometriotic lesions with (conventional non-robotic) fluorescence laparoscopy equipment with preoperative or peroperative ICG administration. Assessment will be performed using an intraoperative registration form (see attachment), postoperative video-analysis (with determination of the target-to-background ratio) and with histological confirmation. Biopsies will be taken from suspicious endometriotic areas seen with both the conventional white light mode and NIRF-mode, areas that appear only with white light mode or NIRF-mode and areas without any visible or fluorescent areas. Histologic examination is carried out on the biopsies to confirm the diagnosis.	—

Measure

Time frame

Main study parameters/endpoints: Investigate the feasibility of identification of endometriotic lesions with (conventional non-robotic) fluorescence laparoscopy equipment with preoperative or peroperative ICG administration. Assessment will be performed using an intraoperative registration form (see attachment), postoperative video-analysis (with determination of the target-to-background ratio) and with histological confirmation. Biopsies will be taken from suspicious endometriotic areas seen with both the conventional white light mode and NIRF-mode, areas that appear only with white light mode or NIRF-mode and areas without any visible or fluorescent areas. Histologic examination is carried out on the biopsies to confirm the diagnosis.

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results