EndometriosisFIREFLYNCT02038985
Fluorescence Imaging + ICG Dye for Use in the Visual Diagnosis of Endometriosis
A study testing Participants will receive ICG Dye in people with Endometriosis, run by AdventHealth at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Participants will receive ICG Dye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 16 Aug 2016
- Phase
- Interventional
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
- Have symptoms consistent with endometriosis, including the presence of one or more of the following: dysmenorrhea; dyspareunia; chronic pelvic pain (>6 months duration); pressure on the bladder or rectum causing difficult or painful bowel movements; infertility.
- Be willing to undergo planned da Vinci Endometriosis Resection Procedure
Who cannot join
- Known or suspected allergy to iodine, shellfish, or ICG dye
- Presence of medical conditions contraindicating general anesthesia or standard laparoscopic/ robotic surgery
- Active pelvic infection
- Previous history of radiation therapy to the pelvis
- Known or suspected pregnancy
- Presence of anatomy unsuitable for laparoscopic surgery
- Previously undiagnosed intra-abdominal or pelvic malignancy
- Inability of patient to tolerate Trendelenberg position or pneumoperitoneum
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Celebration Health
Celebration, Florida, 34747
About this study
Official title: An Evaluation of Fluorescence Imaging + ICG Dye (Firefly) for Use in the Visual Diagnosis of Endometriosis: A Prospective Study
The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.
Read the detailed description
Fluorescence imaging has been used for visualization of tissue perfusion in colorectal surgery, detection of pathologic primary and metastatic tumors, and measurement of graft patency in cardiovascular surgery. The da Vinci® Firefly Imaging System, through the use of fluorescence imaging, allows surgeons to view high-resolution near infrared images of blood flow and tissue perfusion in real-time during robotic-assisted surgical procedures, such as during a robotic-assisted endometriosis resection.
Using standard white light imaging, endometriotic lesions can appear red and vascular, white and scarred, black, brown, yellow, or almost any color; atypical implants are clear and can seem like normal tissue. However, there are some published reports demonstrating that the lesions of endometriosis are hypervascular and may be visualized radiographically on the basis of this pathologic feature. Because the individual lesions of endometriosis can vary significantly in their appearance under standard white light, using the hypervascular characteristic of this disease along with the Firefly technology may provide consistency in intraoperative visual diagnosis, and thus may aid the detection and resection of endometriosis.
The ability to accurately visualize all the lesions of endometriosis, typical and atypical in appearance, and thus facilitate complete resection of the disease, may have a significant impact on symptomatic relief and disease recurrence. The Firefly Imaging System of fluorescence imaging + ICG dye may allow for more accurate visual diagnosis of endometriosis during a robotic-assisted endometriosis resection procedure, and therefore may have a positive impact for patients with this disease.
This is a prospective, comparison, single-center, observational study to evaluate fluorescence imaging + ICG dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure.
- Conditions
- Endometriosis
- Being tested
- Participants will receive ICG Dye
- Keywords
- Endometriosis, Robotic Surgery, Diagnostic Imaging
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive ICG DyeOther
Participants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis
| Study group | Role | What they receive |
|---|---|---|
| + ICG Dye (Firefly) | Other | Participants will receive ICG Dye Receives: Other: Participants will receive ICG Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of fluorescence imaging using + ICG dye (Firefly).
Quality is defined by the investigators perception of accuracy of visual diagnosis and how clear are the the resultant images used for visualization and mapping of lesions. The quality of the fluorescence imaging + ICG dye (Firefly) will be compared to standard white light imaging in 2D and 3D for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure
Measured: 1 hour
Secondary outcomes (1)
Quality of Life
Quality of Life (QOL) will be captured by utilizing the validated questionnaire SF-36 short form, administered at three time-points: pre-operative, at 3-months post-operative, and at 6-months post-operative. The QOL aspects examined with the SF-36 include vitality, mental health physical functioning, bodily pain, general health perceptions, as well as physical, emotional, and social role functioning.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completion16 Aug 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aileen Caceres, MD, Principal investigator, Florida Hospital Celebration Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038985
- Sponsor's protocol ID
- 451140
- Acronym
- FIREFLY
- Status last verified
- Oct 2017
- First submitted
- 30 Dec 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Fluorescence Imaging + ICG Dye (Firefly) for Use in the Visual Diagnosis of Endometriosis: A Prospective Study
- ClinicalTrials.gov ID
- NCT02038985
- Acronym / sponsor ID
- FIREFLY / 451140
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Robotic Surgery, Diagnostic Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 17 Jan 2014 (estimated)
- 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.
The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.
Detailed description
Fluorescence imaging has been used for visualization of tissue perfusion in colorectal surgery, detection of pathologic primary and metastatic tumors, and measurement of graft patency in cardiovascular surgery. The da Vinci® Firefly Imaging System, through the use of fluorescence imaging, allows surgeons to view high-resolution near infrared images of blood flow and tissue perfusion in real-time during robotic-assisted surgical procedures, such as during a robotic-assisted endometriosis resection.
Using standard white light imaging, endometriotic lesions can appear red and vascular, white and scarred, black, brown, yellow, or almost any color; atypical implants are clear and can seem like normal tissue. However, there are some published reports demonstrating that the lesions of endometriosis are hypervascular and may be visualized radiographically on the basis of this pathologic feature. Because the individual lesions of endometriosis can vary significantly in their appearance under standard white light, using the hypervascular characteristic of this disease along with the Firefly technology may provide consistency in intraoperative visual diagnosis, and thus may aid the detection and resection of endometriosis.
The ability to accurately visualize all the lesions of endometriosis, typical and atypical in appearance, and thus facilitate complete resection of the disease, may have a significant impact on symptomatic relief and disease recurrence. The Firefly Imaging System of fluorescence imaging + ICG dye may allow for more accurate visual diagnosis of endometriosis during a robotic-assisted endometriosis resection procedure, and therefore may have a positive impact for patients with this disease.
This is a prospective, comparison, single-center, observational study to evaluate fluorescence imaging + ICG dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| + ICG Dye (Firefly) | Other | Other: Participants will receive ICG DyeParticipants will receive ICG Dye |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
- Have symptoms consistent with endometriosis, including the presence of one or more of the following: dysmenorrhea; dyspareunia; chronic pelvic pain (>6 months duration); pressure on the bladder or rectum causing difficult or painful bowel movements; infertility.
- Be willing to undergo planned da Vinci Endometriosis Resection Procedure
Key exclusion criteria (8 listed)
- Known or suspected allergy to iodine, shellfish, or ICG dye
- Presence of medical conditions contraindicating general anesthesia or standard laparoscopic/ robotic surgery
- Active pelvic infection
- Previous history of radiation therapy to the pelvis
- Known or suspected pregnancy
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 |
|---|---|---|
| Participants will receive ICG DyeParticipants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis | Other | + ICG Dye (Firefly) |
Primary outcome
Quality of fluorescence imaging using + ICG dye (Firefly).
Time frame: 1 hour
Quality is defined by the investigators perception of accuracy of visual diagnosis and how clear are the the resultant images used for visualization and mapping of lesions. The quality of the fluorescence imaging + ICG dye (Firefly) will be compared to standard white light imaging in 2D and 3D for accurate visual diagnosis of endometriosis during a da Vinci endometriosis resection procedure
1 secondary outcome
Quality of Life
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
Aileen Caceres, MD principal investigator
Florida Hospital Celebration Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants will receive ICG Dye in people with Endometriosis, run by AdventHealth at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Oct 2017. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Quality of fluorescence imaging using + ICG dye (Firefly). (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.