NCT03850158

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

February 19, 2019

Last Update Submit

January 13, 2020

Conditions

EndometriosisLaparoscopyNear Infrared Fluorescence ImagingIndocyanine Green (ICG)

Outcome Measures

Primary Outcomes (1)

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

    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.

    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

Study Arms (1)

Interventional Arm, ICG and NIR imaging

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.

Drug: Indocyanine Green

Interventions

Indocyanine GreenDRUG

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.

Interventional Arm, ICG and NIR imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Siegenthaler F, Knabben L, Mohr S, Nirgianakis K, Imboden S, Mueller MD. Visualization of endometriosis with laparoscopy and near-infrared optics with indocyanine green. Acta Obstet Gynecol Scand. 2020 May;99(5):591-597. doi: 10.1111/aogs.13803. Epub 2020 Jan 28.

    PMID: 31943126DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sara Imboden, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

January 1, 2017

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)