Systemic SclerosisPhase 4NCT03155464
Intraoperative ICG for Systemic Sclerosis
A Phase 4 study testing Order of two elements of surgical procedure and Indocyanine Green in people with Systemic Sclerosis, run by Duke University.
Trial summary
The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Order of two elements of surgical procedure and Indocyanine Green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 23 Jan 2018
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 - 85 years at time of study enrollment.
- Patient has a diagnosis of a systemic sclerosis with vascular obstruction of the hand resulting in digital ischemia, ulceration, and/or gangrene and have failed nonoperative treatments.
- Patient is willing and able to comply with postoperative scheduled clinical evaluations.
Who cannot join
- • Patient is undergoing revision surgery.
- Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
- If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.
- Patient is a prisoner
- Pregnant women confirmed by testing prior to surgery, and nursing mothers
- Patient has an allergy to iodine confirmed during initial history and on day of surgery
About this study
Official title: A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis
The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.
Read the detailed description
A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.
Patients will be randomized to Group 1 or 2. If patients are randomized to Group 1, patients will receive sympathectomy prior to bypass during the surgical procedure (see below). If patients are randomized to Group 2, they will received bypass prior to sympathectomy during the surgical procedure (see below). Patients in both groups will be in the study for the next 12 months. Normal clinical practice will not change. Patients in both groups will be examined before surgery. If they provide consent to participate, demographical data, comorbidities, the number and severity of digital ulcerations, and baseline outcome measures for the Michigan Hand Outcome Questionnaire, Disabilities of the Arm, Shoulder and Hand and the Visual Analogue Scale for Pain will be collected.
Patients in both groups will return to the office for routine follow-up at 2 weeks for wound care. The next study visit will occur at 6 weeks. At that time, outcome measures will be again administered and data collected. In accordance with standard clinical practice, the patients will return to the office for examination again at 6 months and 1 year. At these times, the primary clinical outcomes will be collected as well as the patient reported outcomes.
These are normal visits, not outside the scope of routine clinical practice. Intraoperative ICG is also within the scope of routine clinical practice. The dose of ICG and the number of times that it is administered to subjects is the same as in standard of care.
ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. The laser diode array utilized by the SPY System emits a near-infrared wavelength that does not require the use of protective eyewear or other safety equipment. The investigators will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. Of note, No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
- Conditions
- Systemic Sclerosis
- Being tested
- Order of two elements of surgical procedure, Indocyanine Green
- Keywords
- indocyanine-green, systemic scerlosis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order of two elements of surgical procedureProcedure or surgery
Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.
Indocyanine GreenDrug
Also called ICG
Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Order of two elements of surgical procedure: patients in group 1 will receive sympathectomy prior to bypass during the surgical procedure.
Indocyanine Green (ICG) will be used in both groups. Receives: Procedure: Order of two elements of surgical procedure; Drug: Indocyanine Green |
| Group 2 | Other | Order of two elements of surgical procedure: Patients in group 2 will receive bypass prior to sympathectomy during the surgical procedure.
Indocyanine Green (ICG) will be used in both groups. Receives: Procedure: Order of two elements of surgical procedure; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perfusion
To compare the relative intraoperative change in perfusion between arterial reconstruction and sympathectomies with quantitative ICG.
Measured: Baseline-One Year Follow-up
Secondary outcomes (1)
Intraoperative change in hand and digit perfusion
To document the immediate intraoperative quantitative change in hand and digit perfusion in combined arterial reconstruction and sympathectomies in patients with systemic sclerosis using intraoperative quantitative ICG.
Measured: Baseline-One Year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Why it stopped: The device that was going to be studied was removed by Duke University shortly after the study was approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suhail Mithani, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155464
- Sponsor's protocol ID
- Pro00078686
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2017
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis
- ClinicalTrials.gov ID
- NCT03155464
- Acronym / sponsor ID
- Pro00078686
- Conditions
- Systemic Sclerosis
- Keywords
- indocyanine-green, systemic scerlosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device that was going to be studied was removed by Duke University shortly after the study was approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 16 May 2017 (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.
The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.
Detailed description
A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.
Patients will be randomized to Group 1 or 2. If patients are randomized to Group 1, patients will receive sympathectomy prior to bypass during the surgical procedure (see below). If patients are randomized to Group 2, they will received bypass prior to sympathectomy during the surgical procedure (see below). Patients in both groups will be in the study for the next 12 months. Normal clinical practice will not change. Patients in both groups will be examined before surgery. If they provide consent to participate, demographical data, comorbidities, the number and severity of digital ulcerations, and baseline outcome measures for the Michigan Hand Outcome Questionnaire, Disabilities of the Arm, Shoulder and Hand and the Visual Analogue Scale for Pain will be collected.
Patients in both groups will return to the office for routine follow-up at 2 weeks for wound care. The next study visit will occur at 6 weeks. At that time, outcome measures will be again administered and data collected. In accordance with standard clinical practice, the patients will return to the office for examination again at 6 months and 1 year. At these times, the primary clinical outcomes will be collected as well as the patient reported outcomes.
These are normal visits, not outside the scope of routine clinical practice. Intraoperative ICG is also within the scope of routine clinical practice. The dose of ICG and the number of times that it is administered to subjects is the same as in standard of care.
ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. The laser diode array utilized by the SPY System emits a near-infrared wavelength that does not require the use of protective eyewear or other safety equipment. The investigators will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. Of note, No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: Order of two elements of surgical procedure, Drug: Indocyanine GreenOrder of two elements of surgical procedure: patients in group 1 will receive sympathectomy prior to bypass during the surgical procedure. Indocyanine Green (ICG) will be used in both groups. |
| Group 2 | Other | Procedure: Order of two elements of surgical procedure, Drug: Indocyanine GreenOrder of two elements of surgical procedure: Patients in group 2 will receive bypass prior to sympathectomy during the surgical procedure. Indocyanine Green (ICG) will be used in both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- o Patient has signed an IRB approved, study specific Informed Patient Consent Form.
Key exclusion criteria (6 listed)
- • Patient is undergoing revision surgery.
- If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.
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 |
|---|---|---|
| Order of two elements of surgical procedurePlease see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2. | Procedure or surgery | Group 1, Group 2 |
| Indocyanine GreenAlso: ICGIntraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight. | Drug | Group 1, Group 2 |
Primary outcome
Change in perfusion
Time frame: Baseline-One Year Follow-up
To compare the relative intraoperative change in perfusion between arterial reconstruction and sympathectomies with quantitative ICG.
1 secondary outcome
Intraoperative change in hand and digit perfusion
Time frame: Baseline-One Year Follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Suhail Mithani, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Order of two elements of surgical procedure and Indocyanine Green in people with Systemic Sclerosis, run by Duke University.
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 6 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: withdrawn, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in perfusion (time frame: Baseline-One Year Follow-up). 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 30 Jun 2020.