Ureter InjuryPhase 2NCT03937505
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
A Phase 2 study testing IS-001 and No treatment in people with Ureter Injury, run by Intuitive Surgical at 3 sites in United States.
Trial summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ureter Injury
- What is being tested?
- IS-001 and No treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 May 2019to 22 Jul 2021
- Phase
- Phase 2
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subject is between the ages of 18 and 75, inclusive
- Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
- Subject is willing and able to provide informed consent
- Subject is considered capable of complying with study procedures
Who cannot join
- Subject is pregnant or nursing
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- 4. Subject is already enrolled in another investigational study 5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St.David's Medical Center
Austin, Texas, 78758
Las Palmas Medical Center
El Paso, Texas, 79902
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Read the detailed description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
- Conditions
- Ureter Injury
- Being tested
- IS-001, No treatment
- Keywords
- robotic-assisted surgery, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IS-001Drug
intravenous injection of IS-001 investigational drug
No treatmentDrug
no drug injection
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation | Experimental | Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined. Receives: Drug: IS-001 |
| Optimal dose-characterization | Experimental | Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures. Receives: Drug: IS-001; Drug: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Measured: 10 minutes
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Measured: 30 minutes
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Measured: 60 minutes
Secondary outcomes (25)
Safety 12-Lead EKG Change from Baseline
12-Lead EKG change from baseline in QTc
Measured: 6 hours
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Measured: 24 hours
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Measured: 14 days
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Measured: 24 hours
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Measured: 14 days
Incidence of abnormal urinalysis results
Routine urinalysis laboratory assessment change from baseline
Measured: 14 days
Safety Adverse Events Monitoring
Drug related adverse events monitoring through 14-days
Measured: 14 days
Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels
Maximal concentration of investigational drug-plasma levels (Cmax)
Measured: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)
Area under the plasma curve from t(0) to last plasma sample
Measured: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)
Area under the plasma curve from t(0) extrapolated to infinity
Measured: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Drug Plasma Clearance (CL)
Clearance of the investigational drug from plasma
Measured: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Terminal Elimination Half-life (t1/2)
Half-life of the investigational drug in plasma
Measured: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Apparent Volume of Distribution (Vz)
The apparent volume of distribution of the investigational drug
Measured: 0, 1-2 hours and 2-3 hours
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes
Measured: 10 minutes
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes
Measured: 30 minutes
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes.
Measured: 60 minutes
Ureter Delineation Efficacy as Length of Line Drawn in Millimeters
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Measured: 10 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Measured: 30 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Measured: 60 minutes
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Measured: 10 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Measured: 30 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Measured: 60 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.
Measured: 10 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points
Measured: 30 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.
Measured: 60 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start28 May 2019
- Primary completion8 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter InjuryStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Farnam, MD, Principal investigator, Las Palmas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937505
- Sponsor's protocol ID
- ISI-124804-2
- Status last verified
- Aug 2021
- First submitted
- 29 Apr 2019
- Last updated
- 5 Aug 2021
- 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 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
- ClinicalTrials.gov ID
- NCT03937505
- Acronym / sponsor ID
- ISI-124804-2
- Conditions
- Ureter Injury
- Keywords
- robotic-assisted surgery, minimally invasive surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 3 May 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 safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Detailed description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation | Experimental | Drug: IS-001Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined. |
| Optimal dose-characterization | Experimental | Drug: IS-001, Drug: No treatmentSingle intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female subject is between the ages of 18 and 75, inclusive
- Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
- Subject is willing and able to provide informed consent
- Subject is considered capable of complying with study procedures
Key exclusion criteria (3 listed)
- Subject is pregnant or nursing
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- 4. Subject is already enrolled in another investigational study 5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
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 |
|---|---|---|
| IS-001intravenous injection of IS-001 investigational drug | Drug | Dose-escalation, Optimal dose-characterization |
| No treatmentno drug injection | Drug | Optimal dose-characterization |
Primary outcome
Evaluate fluorescent intensity of ureter by signal to background analysis
Time frame: 10 minutes
Fluorescent intensity of ureter evaluated as signal to background
Evaluate fluorescent intensity of ureter by signal to background analysis
Time frame: 30 minutes
Fluorescent intensity of ureter evaluated as signal to background
Evaluate fluorescent intensity of ureter by signal to background analysis
Time frame: 60 minutes
Fluorescent intensity of ureter evaluated as signal to background
25 secondary outcomes
Safety 12-Lead EKG Change from Baseline
Time frame: 6 hours
Incidence of abnormal blood work in tests results
Time frame: 24 hours
Incidence of abnormal blood work in tests results
Time frame: 14 days
Incidence of abnormal blood work in tests results
Time frame: 24 hours
Incidence of abnormal blood work in tests results
Time frame: 14 days
Incidence of abnormal urinalysis results
Time frame: 14 days
Safety Adverse Events Monitoring
Time frame: 14 days
Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Drug Plasma Clearance (CL)
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Terminal Elimination Half-life (t1/2)
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Apparent Volume of Distribution (Vz)
Time frame: 0, 1-2 hours and 2-3 hours
Ureter Identification Efficacy on a Nominal Scale
Time frame: 10 minutes
Ureter Identification Efficacy on a Nominal Scale
Time frame: 30 minutes
Ureter Identification Efficacy on a Nominal Scale
Time frame: 60 minutes
Ureter Delineation Efficacy as Length of Line Drawn in Millimeters
Time frame: 10 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Time frame: 30 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Time frame: 60 minutes
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Time frame: 10 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Time frame: 30 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Time frame: 60 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Time frame: 10 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Time frame: 30 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Time frame: 60 minutes post-dose
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 5 Aug 2021.
- 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.
Richard Farnam, MD principal investigator
Las Palmas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IS-001 and No treatment in people with Ureter Injury, run by Intuitive Surgical at 3 sites 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 4 inclusion and 3 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluate fluorescent intensity of ureter by signal to background analysis (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 5 Aug 2021.