EndometriosisEarly Phase 1NCT03850158
Diagnostic Value of ICG in Endometriosis
A Early Phase 1 study testing Indocyanine Green in people with Endometriosis and Laparoscopy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Laparoscopy, Near Infrared Fluorescence Imaging
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital
Bern, 3010
About this study
Official title: Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.
Read the 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.
- Being tested
- Indocyanine Green
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startJan 2017
- Primary completionNov 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Imboden, MD, Principal investigator, Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850158
- Sponsor's protocol ID
- Study ID 3300
- Status last verified
- Jan 2020
- First submitted
- 19 Feb 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31943126
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
- ClinicalTrials.gov ID
- NCT03850158
- Acronym / sponsor ID
- Study ID 3300
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm, ICG and NIR imaging | Experimental | Drug: Indocyanine GreenNIR 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenIndocyanine 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. | Drug | Interventional Arm, ICG and NIR imaging |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 31943126Siegenthaler 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.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Imboden, MD principal investigator
Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Indocyanine Green in people with Endometriosis and Laparoscopy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03850158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.