Trials / Completed
CompletedNCT03850158
Diagnostic Value of ICG in Endometriosis
Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Indocyanine Green | 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. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-11-01
- Completion
- 2019-12-01
- First posted
- 2019-02-21
- Last updated
- 2020-01-18
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03850158. Inclusion in this directory is not an endorsement.